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The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit
G Model JICC 475 No. of Pages 5
Journal of Indian College of Cardiology xxx (2018) xxx–xxx
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The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit Wael Ali Khalil* , Waleed El- Awady, Mahmoud Diaa El-Menshawy, Mohammad Emad Cardiology department, Faculty of Medicine, Zagazig University, Egypt
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 April 2018 Accepted 20 October 2018 Available online xxx
Background: Contrast induced nephropathy (CIN) which is following the administration of radiographic contrast media in coronary intervention results in increased morbidity and mortality. Several prophylactic methods were done to prevent CIN post coronary intervention. Aim of the work: To evaluate contrast media volume to creatinine clearance (V/CrCl) ratio for predicting (CIN) and to determine a safe contrast media volume to prevent CIN post Coronary interventions in catheterization unit. Patients and methods: This study was carried out in ——— Cardiac Catheterization Unit and included 315 patients who underwent coronary intervention. Inclusion criteria: Coronary angiography, PCI,. Exclusion criteria: Acute renal failure, Dialysis- dependant chronic renal failure. Blood urea, serum creatinine and Creatinine clearance were measured and calculated for all patients in the day before coronary angiography and then daily after the procedure for three days after the procedure. Results: The patients were divided into four groups; Group I: 77 patients who have V/Cr.Cl <1. Group II:79 patients who have V/Cr.Cl (1.07–2.3).Group III: 78 patients who have V/Cr.Cl (2.3–3.31). Group IV: 80 patients who have V/Cr.Cl >3.31. The optimal cut off level for the V/CrCl ratio for predicting CIN was >2.8593 (85.3% sensitivity & 79.6% specificity) and is an independent risk factor of CIN. Conclusion: a reduction in the contrast media volume to a V/CrCl ratio <2.85 is a new predictors for early diagnosis and prevention of CIN post cardiac catheterization in patients with relatively normal renal function. © 2018 Indian College of Cardiology. All rights reserved.
Keywords: Contrast induced nephropathy Safe contrast volume and coronary intervention
1. Introduction
1.1. Aim of the work
CIN is the development of acute kidney injury following the administration of contrast dye without any other known causes of acute kidney injury. It is defined as an increase in the serum creatinine (Scr) level of 25% or an increase of 0.5 mg/dl from baseline within 48–72 h of contrast media exposure. CIN results in prolonged hospital stay, increased morbidity, and higher mortality.1 The higher incidence of CIN in patients with pre-existing renal impairment, diabetes mellitus, old age, anemia, hypovolumia, heart failure, increased amount and type of contrast media.2 Several methods have been studied to prevent (CIN) including I.V. saline, sodium bicarbonate, dopamine, atrial natriuretic peptide.3 A safe contrast media dose based on renal function has been proven to effectively prevent CIN.4
To evaluate contrast media volume to creatinine clearance (V/ CrCl) ratio for predicting (CIN) and to determine a safe contrast media volume to prevent CIN post Coronary interventions in catheterization unit (Figs. 1 and 2). 1.2. Patients and methods This study was carried out in Cardiac Catheterization Unit and included 315 patients who underwent coronary intervention. 1.3. Inclusion criteria Coronary angiography, PCI, Normal and slightly elevated creatinine levels (< 1.5 mg/dl). 1.4. Exclusion criteria
* Corresponding author at: Cardiology Department, Zagazig University, Egypt. E-mail address: [email protected] (W.A. Khalil).
Acute renal failure, Dialysis- dependant chronic renal failure.
https://doi.org/10.1016/j.jicc.2018.10.001 1561-8811/© 2018 Indian College of Cardiology. All rights reserved.
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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1.7. (II)Renal function tests
Fig. 1. The Relationship between the contrast volume to creatinine clearance ratio and the percentage of patients with CIN after cardiac catheterization (P<0.001).
Blood urea and serum creatinine were measured for all patients in the day before coronary intervention and then daily after the procedure for three days. Four milliliters of venous blood were taken for each determination of renal function. Blood urea was determined by urease-modified Berthelot reaction. Serum creatinine was determined by Jaffe` reaction.7 Creatinine clearance was calculated for all patients in the day before coronary intervention and daily after the procedure for 72 h. It was calculated according to Cockroft-Gault formula; Creatinine clearance (ml/ min) = (140Age) xTotal body weight (kilograms) 72 x Serum creatinine (mg/ dl) (x 0.85 for women). Normal creatinine clearance is 90–140 ml/ min for males, 80–125 ml/min for females. The Normal range for creatinine 0.5–1.4 mg/dl (71–106 mmol/L).8 1.8. (III) Coronary intervention
Fig. 2. ROC curve analysis for detection of CIN; demonstrated that the area under the curve (AUC) for the V/CrCl ratio was (0.887, P<0.001). The optimal cut off level for the V/CrCl ratio was >2.8593, which exhibited 85.3% sensitivity and 79.6% specificity for predicting CIN.
1.5. The primary end point It was the occurrence of contrast medium-induced nephrotoxicity which was defined as impairment in renal functions (an increase in serum creatinine by > 25% above the basal level or 0.5 mg/dl) occurring within 48–72 hrs after the intravascular administration of contrast dye in the absence of any other cause.5 1.6. (I)all patients were subjected to Through history taking was done for all patients with special stress on the following: Age, gender and Risk factors of coronary artery disease; (hypertension, diabetes mellitus, smoking, dyslipidemia and family history of premature coronary artery disease). Drug history for nephrotoxic drugs as non-steroidal anti-inflammatory drugs (NSAIDs), Aminoglycosides, Angiotensin receptor blockers and angiotensin converting enzyme inhibitors. Risk factors for contrast induced nephropathy (pre-existing renal dysfunction, repeated exposure to contrast medium within 72 h). Clinical examination was done to all patients with special stress on; Pulse, blood pressure, height of the patient in meters, weight in kilograms, body mass index BMI was calculated as follows, BMI is weight in kg / height in m2. A conventional twelve leads surface ECG was done for all patients before coronary angiography. Echocardiography was done before coronary angiography according to the recommendations of the American society of echocardiography.6
1.8.1. (Diagnostic coronary angiography or PCI) All patients with creatinine < 1.5 mg/dl were given normal saline 0.9% intravenously, at a rate of 1 ml/kg/hour, for twelve hours before coronary angiography, and for twelve hours after the procedure. The patients were not given the other prophylactic measures to prevent CIN as atrial natriuretic peptide, mannitol, calcium channel blockers (CCBs), furosemide or theophylline. The amount and type of dye used in the coronary intervention is calculated. The contrast media volume to creatinine clearance (V/ CrCl) ratio is calculated. (A)The patients were divided according to presence or absence of contrast induced nephropathy (CIN). (B) The patients were divided into four groups according to V/Cr.Cl ratio: Group I: It included 77 patients who have V/Cr.Cl <1. It included 49 males, 28 females. Twenty patients were diabetic and forty five patients were hypertensive. Group II: It included 79 patients who have V/Cr.Cl (1.07–2.3). It included 66 males and 13 females. Fourty patients were diabetic and thirty three patients were hypertensive. Group III: It included 78 patients who have V/Cr.Cl (2.3–3.31). It included 56 males and 22 females. Thirty six patients were diabetic and thirty seven patients were hypertensive. Group IV: It included 80 patients who have V/Cr.Cl >3.31. It It included 54 males and 26 females. Thirty nine patients were diabetic and forty nine three patients were hypertensive 2. Ethical consideration This study was approved by Ethics Committee of Faculty of Medicine, ——— University, Egypt. A written consent from every patient to participate in the study was obtained and the study was consistence with ethical standards. 3. Statistical analysis Data were entered using SPSS version 22 (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA). Data was summarized using mean, standard deviation. Comparisons between quantitative variables were done using analysis of variance (ANOVA) in normally distributed data and the non-parametric Mann-Whitney tests were used in data that are not normally distributed. Chi square (χ2) test was performed to compare categorical data. Exact test was used instead when the expected frequency is less than 5. ROC curve was constructed with area under curve analysis performed to detect the best cutoff value of volume/Cr.Cl for detection of CIN. Univariate and multivariate logistic regressions were done to detect independent predictors of
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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CIN. P-values less than 0.05 were considered as statistically significant.
3
Table 2 Risk factors in Patients with and without CIN. CIN
4. The results
P value
yes
4.1. The results of the Demographic and clinical criteria of the patients with or without CIN (Tables 1 and 2) According to our study results: the patients with CIN were older in age, known to have diabetic, hypertensive and had higher levels of pre procedural renal function than the patients without CIN. The higher ratios of V/CrCl were more prevalent in the patients with CIN. The results of the Demographic and clinical criteria of the patients according to the V/ Cr Cl ratio quartiles (Tables 3 and 4): the patients with CIN were older in age, obese known to have diabetic, hypertensive and had higher levels of pre procedural renal. The Statistical analysis revealed a significant difference between groups as regards demographic & clinical criteria of the patients (p < 0.001). According to the univariate logistic regression analysis, a V/CrCl ratio >2.859 was a significant predictor of CIN (OR = 22.691, 95% CI 8.409–61.23, P < 0.001). In the multivariate analysis, a V/CrCl ratio of >2.859 (OR = 25.092, 95% CI 8.481–74.237, P < 0.001) remained an independent risk factor of CIN after adjusting for other potential risk factors (Tables 5 and 6 ). 5. Discussion The present study was performed to find the early predictor for detection and prevetion of CIN in our cath lab. The prevention of CIN in patients with relatively normal renal function is challaning during coronary intervention. In our study The early predictor of CIN is contrast volume to creatinine clearance ratio (V/CrCl ratio >2.85). In clinical practice, patients with elevated baseline Serum Cr should receive sufficient peri-procedural CIN prophylaxis, and early calculation of the safe contrast dye dose based on renal function before the procedure according to guidelines from the European Society of Cardiology9 the American College of Cardiology.10 However, in low risk patients for CIN with normal Serum Cr values donot receive any prophylactic measures for CIN. In many studies the patients with normal serum Cr was similar to patients with chronic renal impairement in developing CIN post cardiac catherization with similar poor prognosis.11 In another study the increase in 0.5 mg/dl of serum creatinine was an independent predictor of in-hospital cardiac events in patients with normal renal function.12 A large contrast media volume is a early contributor to CIN in patients with normal renal function, 11
sex Smoking DM HTN Prem.CAD dyslipidemia
Female Male yes no yes no yes no yes no yes no
no
Count
%
Count
%
10 24 11 23 21 13 28 6 3 31 15 19
29.4% 70.6% 32.4% 67.6% 61.8% 38.2% 82.4% 17.6% 8.8% 91.2% 44.1% 55.9%
79 201 125 155 116 164 136 144 34 246 62 218
28.2% 71.8% 44.6% 55.4% 41.4% 58.6% 48.6% 51.4% 12.1% 87.9% 22.1% 77.9%
0.884 0.172 0.024 < 0.001 0.780 0.005
and a reduction in contrast media volume has been reported to be a possible means for preventing CIN. Therefore, determining the safe contrast media volume is important for preventing CIN. Several cut off values for safe contrast media volume have been reported. The V/CrCl ratio represents the contrast media dose and renal function. This index can predict the safety profile of contrast dye than the absolute contrast volume alone.13 The V/CrCl ratio is applicable method for determining the maximum safe contrast volume and is a predictor of CIN following cardiac catheterization. Another study observed that a V/CrCl ratio >3.7 demonstrated the optimal sensitivity and specificity for detecting CIN, and it is an independent predictor for CIN.14 Our study demonstrated that the V/CrCl ratio of >2.859 remained an independent risk factor of CIN after adjusting for other potential risk factors. Another study had reported that the cut off value for the V/CrCl ratio was2.60 in patients with diabetes mellitus undergoing elective PCI which is in accordance with our study result.15 About 1020 patients with normal renal function were enrolled in one study the age of patients >65 years with (baseline serum creatinine <1.5 mg/dl) undergoing PCI. Receiver operating characteristic (ROC) curves were used to identify the optimal cut off value of V/CrCl for detecting CIN. Thirty-nine patients (3.8%) developed CIN. There was a significant association between a higher V/CrCl ratio and CIN risk (P < 0.001). ROC curve analysis indicated that a V/CrCl ratio of 2.74 was a fair discriminator for CIN (C statistic = 0.68). After adjusting for other known CIN risk factors, V/CrCl ratios >2.74 remained significantly associated with CIN (odds ratio = 3.21, 95% confidence interval [CI] 1.45–7.09, P = 0.004). 16 However, the present study demonstrated the optimal cut off value for the V/CrCl ratio (2.85) in patients with relatively normal renal function
Table 1 Demographic and clinical criteria of the patients with or without CIN. P value
CIN yes
age body Wt. Volume of dye SBP DBP Cr before urea before Cr.Cl.before S.creat after S.urea after Cr.Cl after V/Cr.Cl before
no
Mean
SD
Median
Minimum
Maximum
Mean
SD
Median
Minimum
Maximum
59.41 78.82 285.59 140.59 81.76 1.38 34.24 65.96 2.56 62.53 39.72 4.93
9.99 9.46 94.68 34.37 9.04 .38 13.04 24.54 .98 44.05 22.12 2.46
60.00 77.50 300.00 130.00 80.00 1.60 32.00 58.20 2.30 44.00 35.25 4.60
35.00 70.00 130.00 100.00 70.00 .70 15.00 40.68 .70 20.00 14.37 1.33
84.00 110.00 500.00 250.00 100.00 1.80 78.00 128.00 4.60 158.00 113.43 11.26
54.08 80.38 152.00 128.14 79.86 .99 26.71 99.14 .97 27.26 100.50 1.82
9.54 11.79 89.86 15.80 9.78 .25 7.34 31.31 .25 6.78 31.17 1.44
53.00 80.00 135.00 130.00 80.00 1.00 26.00 96.28 .90 26.00 96.65 1.30
32.00 60.00 50.00 90.00 60.00 .47 12.00 25.76 .60 15.00 26.40 .27
84.00 140.00 500.00 180.00 100.00 2.20 57.30 189.90 2.00 55.00 215.78 10.91
0.002 0.574 <0.001 0.037 0.278 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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Table 3 Baseline Characteristics of the V/ CrCl Ratio Quartiles. V/CrCl Quartiles
P value
Q1
age body Wt. Volume of dye SBP DBP S.creat before S.urea before Cr.Cl.before S.creat after S.urea after Cr.Cl after
Q2
Q3
Q4
Mean
SD
Mean
SD
Mean
SD
Mean
SD
50.71 89.61 65.84 136.10 85.06 .85 26.89 129.01 .84 27.81 129.65
7.58 13.82 7.88 14.23 9.55 .15 7.15 28.41 .13 6.27 30.53
53.24 80.49 107.47 131.14 79.37 1.00 26.84 100.32 1.01 27.73 98.49
7.53 9.51 39.07 23.92 8.33 .20 8.51 24.21 .28 9.41 23.51
54.95 75.44 205.51 122.69 78.08 .99 25.29 89.12 1.07 29.23 84.35
10.63 7.44 50.37 14.56 8.80 .23 5.05 19.96 .44 18.66 22.03
59.57 75.55 283.50 128.12 77.88 1.30 31.00 64.91 1.62 39.32 64.33
10.52 8.49 79.65 19.36 10.40 .35 10.94 16.92 .98 29.86 29.92
< < < < < < < < < < <
0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001
Table 4 Baseline clinical features of the V/ CrCl Ratio Quartiles. V/CrCl Quartiles
P value Q2
Q1
sex presentation
Smoking DM HTN Prem.CAD dyslipidemic Echo
age
Female Male chest pain Dyspnea epigastric pain yes no yes no yes no yes no yes no Positive for ishaemia RHD Negativefor ishaemia less than 50 years more than 50 years
P value
OR
Age >50 years VCrCl>2.8593 Smoking DM HTN Multi vessel disease Dyslipidemia
0.042 < 0.001 0.176 0.027 0.001 0.201 0.006
2.459 22.691 0.593 2.284 4.941 1.593 2.776
Q4
Count
%
Count
%
Count
%
Count
%
28 49 71 4 2 25 52 22 55 45 32 7 70 16 61 49 8 20 45 32
36.4% 63.6% 92.2% 5.2% 2.6% 32.5% 67.5% 28.6% 71.4% 58.4% 41.6% 9.1% 90.9% 20.8% 79.2% 63.6% 10.4% 26.0% 58.4% 41.6%
13 66 70 5 4 43 36 40 39 33 46 13 66 16 63 36 2 41 27 52
16.5% 83.5% 88.6% 6.3% 5.1% 54.4% 45.6% 50.6% 49.4% 41.8% 58.2% 16.5% 83.5% 20.3% 79.7% 45.6% 2.5% 51.9% 34.2% 65.8%
22 56 63 10 5 40 38 36 42 37 41 13 65 24 54 40 2 36 25 53
28.2% 71.8% 80.8% 12.8% 6.4% 51.3% 48.7% 46.2% 53.8% 47.4% 52.6% 16.7% 83.3% 30.8% 69.2% 51.3% 2.6% 46.2% 32.1% 67.9%
26 54 68 4 8 28 52 39 41 49 31 4 76 21 59 45 0 35 19 61
32.5% 67.5% 85.0% 5.0% 10.0% 35.0% 65.0% 48.8% 51.2% 61.2% 38.8% 5.0% 95.0% 26.2% 73.8% 56.2% .0% 43.8% 23.8% 76.2%
Table 5 Univariate logistic regression analysis to detect independent predictors of CIN. Variables
Q3
95.0% C.I. Lower
Upper
1.035 8.409 0.278 1.099 1.984 0.780 1.333
5.841 61.23 1.263 4.746 12.304 3.252 5.780
undergoing coronary intervention either diagnostic or PCI. The difference in cut off values for the V/CrCl ratio can be explained by the use of different timing for measuring serum Cr post coronary interventions (48–72 h or 24 h) and the different types of patients with chronic kidney disease, STEMI, and DM. It is known that Mehran score was used for CIN evaluation only after dye exposure.2 The Mehran risk score is the most widely used and classic model for CIN,and it has clinical and procedural factors, including age >75years, dye volume,and the presence of chronic heart failure, hypotension, anemia, DM and chronic kideny disease.
0.035 0.231
0.008 0.021 0.046 0.057 0.371 0.001
< 0.001
The best cut off value for the V/CrCl ratio plays an important role in calculating the safe dye dose for preventing of the CIN before the procedure and the early dectection of CIN post cardiac catherization.The direct toxicity by contrast media can lead to apoptosis and cell death of both endothelial and tubular cells, and could be related to harmful effects of free radicals and oxidative stress, resulting in the development of CIN.17 There is, a general agreement of using the small contrast media volume and the avoidance of repetitive coronary intervention. This represents one of the most important recommendations to prevent contrastassociated nephrotoxicity. (This is the defention of low dose Table 6 Multivariate logistic regression analysis to detect independent predictors of CIN. Variables
Age >50 years VCrCl>2.8593 Smoking DM HTN Multi vessel disease Dyslipidemia
P value
.393 <0.001 .659 .241 .035 .054 .013
OR
1.629 25.092 1.247 1.742 3.199 2.452 3.539
95.0% C.I. Lower
Upper
.532 8.481 .468 .689 1.084 .983 1.311
4.989 74.237 3.320 4.409 9.442 6.116 9.554
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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contrast media) : A low dose of contrast media was defined as <70 ml, <125 ml or <5 ml/kg (to a maximum of 300 ml), divided by the plasma creatinine concentration and (IF we are using low dose contrast media less than 100 ml there were no patients requring dialysis) there were no patients who received <100 ml of contrast dye required dialysis after low dose contrast media exposure.18 Briguori et al was In agreement with us who found a positive correlation between the volume of dye and the creatinine concentration.19
2.
3. 4.
5.
6. Conclusion A reduction in the contrast media volume to a V/CrCl ratio <2.85 is a new predictors for early diagnosis and prevention of CIN post cardiac catheterization in patients with relatively normal renal function.
6.
7. 8.
6.1. Recommendation This index (V/CrCl ratio) may be applied to calculate the safe volume of contrast media that used during coronary intervention without increasing the risk of CIN in normal renal function patients and if this index is >2.85 early post coronary procedure we can start early management of CIN without delay to 72 h. 6.2. Limitations Small number of patients groups and single centre study.
9.
10.
11.
12.
Disclosure statement 13.
The authors declare no conflicts of interest. 14.
Financial disclosures The authors declare no grants or funding supports or nonfinancial supports were given to this research.
15.
Acknowledgements
16.
To all patients and staff of cardiology department & cath lab for participation in this research work and starting a prevention program for contrast induced nephropathy in catheterization lab.
17. 18.
References 19. 1. Worasuwannarak S, Pornratanarangsi S. Prediction of contrast-induced nephropathy in diabetic patients undergoing elective cardiac catheterization or PCI: role of volume-to-creatinine clearance ratio and iodine
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dose-to-creatinine clearance ratio. J Med Assoc Thai. 2010;93(January Suppl. (1)):S29–S34. Mehran R, Aymong ED, Nikolsky E, et al. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004;44(7):1393–1399. Solomon R, Tasanarong A. Side effects of radiographic contrast media: pathogenesis, risk factors, and prevention. Biomed Res Int. 2014;2014:1–20. Capodanno D, Ministeri M, Cumbo S. Catheter Cardiovasc Volume-tocreatinine clearance ratio in patients undergoing coronary angiography with or without percutaneous coronary intervention: implications of varying definitions of contrast-induced nephropathy. Intervention. 2014;83(May 6):907–912. Marenzi G, Lauri G, Assanelli E, et al. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004;44:1780–1785. Lang Roberto M, Badano Luigi P, Mor-Avi Victor, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the american society of echocardiography and the European Association of cardiovascular imaging. J Am Soc Echocardiogr. 2015;28:1–39. Levey AS, Perrone RD, Madias NE. Serum creatinine and renal function. Annu Rev Med. 1988;39:465–490. Botev Rossini, Mallié Jean-Pierre, Couchoud Cecilé, et al. Estimating glomerular filtration rate: Cockcroft–Gault and modification of diet in renal disease formulas compared to renal inulin clearance. Clin J Am Soc Nephrol. 2009;4(May 5):899–906. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization . . . - NCBI. https://www.ncbi.nlm.nih.gov/pubmed/ 25173339. Anderson JL, Adams CD, Antman EM, et al. ACCF/AHA focused update incorporated into the ACC/AHA 2007 guidelines for the management of patients with unstable angina : a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;2011(123):e426–e579. Chong E, Poh KK, Liang S, et al. Risk factors and clinical outcomes for contrastinduced nephropathy after percutaneous coronary intervention in patients with normal serum creatinine. Ann Acad Med Singapore. 2010;39:374–380. Raposeiras-Roubin S, Aguiar-Souto P, Barreiro-Pardal C, et al. GRACE risk score predicts contrast-induced nephropathy in patients with acute coronary syndrome and normal renal function. Angiology. 2013;64:31–39. Dangas G, Iakovou I, Nikolsky E, et al. Contrast-induced nephropathy after percutaneous coronary interventions in relation to chronic kidney disease and hemodynamic variables. Am J Cardiol. 2005;95:13–19. Laskey WK, Jenkins C, Selzer F, et al. A pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am Coll Cardiol. 2007;50:584–590. Worasuwannarak S, Pornratanarangsi S. Prediction of contrast-induced nephropathy in diabetic patients undergoing elective cardiac catheterization or PCI: role of volume-to-creatinine clearance ratio and iodine dose-to-creatinine clearance ratio. J Med Assoc Thai. 2010;93(Suppl 1):S29– S34. Liu Yong, Liu Yuan-hui, Chen Ji-yan. Safe contrast volumes for preventing contrast-induced nephropathy in elderly patients with relatively normal renal function during percutaneous coronary. Interv Med (Baltimore). 2015;94 (March 12):e615. Andreucci M, Faga T, Pisani A, et al. Acute kidney injury by radiographic contrast media: pathogenesis and prevention. Biomed Res Int. 2014;2014:1–20. McCullough PA, Williams FJ, Stivers DN, et al. Neutrophil gelatinase-associated lipocalin: a novel marker of contrast nephropathy risk. Am J Nephrol. 2012;35 (6):509–514. Briguori C, Manganelli F, Scarpato P, et al. Acetylcysteine and contrast agentassociated nephrotoxicity. J Am Coll Cardiol. 2002;40:298–30310.1016/S07351097(02)01958-7.
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
Journal of Indian College of Cardiology xxx (2018) xxx–xxx
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Journal of Indian College of Cardiology journal homepage: www.elsevier.com/locate/jicc
The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit Wael Ali Khalil* , Waleed El- Awady, Mahmoud Diaa El-Menshawy, Mohammad Emad Cardiology department, Faculty of Medicine, Zagazig University, Egypt
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 April 2018 Accepted 20 October 2018 Available online xxx
Background: Contrast induced nephropathy (CIN) which is following the administration of radiographic contrast media in coronary intervention results in increased morbidity and mortality. Several prophylactic methods were done to prevent CIN post coronary intervention. Aim of the work: To evaluate contrast media volume to creatinine clearance (V/CrCl) ratio for predicting (CIN) and to determine a safe contrast media volume to prevent CIN post Coronary interventions in catheterization unit. Patients and methods: This study was carried out in ——— Cardiac Catheterization Unit and included 315 patients who underwent coronary intervention. Inclusion criteria: Coronary angiography, PCI,. Exclusion criteria: Acute renal failure, Dialysis- dependant chronic renal failure. Blood urea, serum creatinine and Creatinine clearance were measured and calculated for all patients in the day before coronary angiography and then daily after the procedure for three days after the procedure. Results: The patients were divided into four groups; Group I: 77 patients who have V/Cr.Cl <1. Group II:79 patients who have V/Cr.Cl (1.07–2.3).Group III: 78 patients who have V/Cr.Cl (2.3–3.31). Group IV: 80 patients who have V/Cr.Cl >3.31. The optimal cut off level for the V/CrCl ratio for predicting CIN was >2.8593 (85.3% sensitivity & 79.6% specificity) and is an independent risk factor of CIN. Conclusion: a reduction in the contrast media volume to a V/CrCl ratio <2.85 is a new predictors for early diagnosis and prevention of CIN post cardiac catheterization in patients with relatively normal renal function. © 2018 Indian College of Cardiology. All rights reserved.
Keywords: Contrast induced nephropathy Safe contrast volume and coronary intervention
1. Introduction
1.1. Aim of the work
CIN is the development of acute kidney injury following the administration of contrast dye without any other known causes of acute kidney injury. It is defined as an increase in the serum creatinine (Scr) level of 25% or an increase of 0.5 mg/dl from baseline within 48–72 h of contrast media exposure. CIN results in prolonged hospital stay, increased morbidity, and higher mortality.1 The higher incidence of CIN in patients with pre-existing renal impairment, diabetes mellitus, old age, anemia, hypovolumia, heart failure, increased amount and type of contrast media.2 Several methods have been studied to prevent (CIN) including I.V. saline, sodium bicarbonate, dopamine, atrial natriuretic peptide.3 A safe contrast media dose based on renal function has been proven to effectively prevent CIN.4
To evaluate contrast media volume to creatinine clearance (V/ CrCl) ratio for predicting (CIN) and to determine a safe contrast media volume to prevent CIN post Coronary interventions in catheterization unit (Figs. 1 and 2). 1.2. Patients and methods This study was carried out in Cardiac Catheterization Unit and included 315 patients who underwent coronary intervention. 1.3. Inclusion criteria Coronary angiography, PCI, Normal and slightly elevated creatinine levels (< 1.5 mg/dl). 1.4. Exclusion criteria
* Corresponding author at: Cardiology Department, Zagazig University, Egypt. E-mail address: [email protected] (W.A. Khalil).
Acute renal failure, Dialysis- dependant chronic renal failure.
https://doi.org/10.1016/j.jicc.2018.10.001 1561-8811/© 2018 Indian College of Cardiology. All rights reserved.
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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1.7. (II)Renal function tests
Fig. 1. The Relationship between the contrast volume to creatinine clearance ratio and the percentage of patients with CIN after cardiac catheterization (P<0.001).
Blood urea and serum creatinine were measured for all patients in the day before coronary intervention and then daily after the procedure for three days. Four milliliters of venous blood were taken for each determination of renal function. Blood urea was determined by urease-modified Berthelot reaction. Serum creatinine was determined by Jaffe` reaction.7 Creatinine clearance was calculated for all patients in the day before coronary intervention and daily after the procedure for 72 h. It was calculated according to Cockroft-Gault formula; Creatinine clearance (ml/ min) = (140Age) xTotal body weight (kilograms) 72 x Serum creatinine (mg/ dl) (x 0.85 for women). Normal creatinine clearance is 90–140 ml/ min for males, 80–125 ml/min for females. The Normal range for creatinine 0.5–1.4 mg/dl (71–106 mmol/L).8 1.8. (III) Coronary intervention
Fig. 2. ROC curve analysis for detection of CIN; demonstrated that the area under the curve (AUC) for the V/CrCl ratio was (0.887, P<0.001). The optimal cut off level for the V/CrCl ratio was >2.8593, which exhibited 85.3% sensitivity and 79.6% specificity for predicting CIN.
1.5. The primary end point It was the occurrence of contrast medium-induced nephrotoxicity which was defined as impairment in renal functions (an increase in serum creatinine by > 25% above the basal level or 0.5 mg/dl) occurring within 48–72 hrs after the intravascular administration of contrast dye in the absence of any other cause.5 1.6. (I)all patients were subjected to Through history taking was done for all patients with special stress on the following: Age, gender and Risk factors of coronary artery disease; (hypertension, diabetes mellitus, smoking, dyslipidemia and family history of premature coronary artery disease). Drug history for nephrotoxic drugs as non-steroidal anti-inflammatory drugs (NSAIDs), Aminoglycosides, Angiotensin receptor blockers and angiotensin converting enzyme inhibitors. Risk factors for contrast induced nephropathy (pre-existing renal dysfunction, repeated exposure to contrast medium within 72 h). Clinical examination was done to all patients with special stress on; Pulse, blood pressure, height of the patient in meters, weight in kilograms, body mass index BMI was calculated as follows, BMI is weight in kg / height in m2. A conventional twelve leads surface ECG was done for all patients before coronary angiography. Echocardiography was done before coronary angiography according to the recommendations of the American society of echocardiography.6
1.8.1. (Diagnostic coronary angiography or PCI) All patients with creatinine < 1.5 mg/dl were given normal saline 0.9% intravenously, at a rate of 1 ml/kg/hour, for twelve hours before coronary angiography, and for twelve hours after the procedure. The patients were not given the other prophylactic measures to prevent CIN as atrial natriuretic peptide, mannitol, calcium channel blockers (CCBs), furosemide or theophylline. The amount and type of dye used in the coronary intervention is calculated. The contrast media volume to creatinine clearance (V/ CrCl) ratio is calculated. (A)The patients were divided according to presence or absence of contrast induced nephropathy (CIN). (B) The patients were divided into four groups according to V/Cr.Cl ratio: Group I: It included 77 patients who have V/Cr.Cl <1. It included 49 males, 28 females. Twenty patients were diabetic and forty five patients were hypertensive. Group II: It included 79 patients who have V/Cr.Cl (1.07–2.3). It included 66 males and 13 females. Fourty patients were diabetic and thirty three patients were hypertensive. Group III: It included 78 patients who have V/Cr.Cl (2.3–3.31). It included 56 males and 22 females. Thirty six patients were diabetic and thirty seven patients were hypertensive. Group IV: It included 80 patients who have V/Cr.Cl >3.31. It It included 54 males and 26 females. Thirty nine patients were diabetic and forty nine three patients were hypertensive 2. Ethical consideration This study was approved by Ethics Committee of Faculty of Medicine, ——— University, Egypt. A written consent from every patient to participate in the study was obtained and the study was consistence with ethical standards. 3. Statistical analysis Data were entered using SPSS version 22 (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA). Data was summarized using mean, standard deviation. Comparisons between quantitative variables were done using analysis of variance (ANOVA) in normally distributed data and the non-parametric Mann-Whitney tests were used in data that are not normally distributed. Chi square (χ2) test was performed to compare categorical data. Exact test was used instead when the expected frequency is less than 5. ROC curve was constructed with area under curve analysis performed to detect the best cutoff value of volume/Cr.Cl for detection of CIN. Univariate and multivariate logistic regressions were done to detect independent predictors of
Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001
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CIN. P-values less than 0.05 were considered as statistically significant.
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Table 2 Risk factors in Patients with and without CIN. CIN
4. The results
P value
yes
4.1. The results of the Demographic and clinical criteria of the patients with or without CIN (Tables 1 and 2) According to our study results: the patients with CIN were older in age, known to have diabetic, hypertensive and had higher levels of pre procedural renal function than the patients without CIN. The higher ratios of V/CrCl were more prevalent in the patients with CIN. The results of the Demographic and clinical criteria of the patients according to the V/ Cr Cl ratio quartiles (Tables 3 and 4): the patients with CIN were older in age, obese known to have diabetic, hypertensive and had higher levels of pre procedural renal. The Statistical analysis revealed a significant difference between groups as regards demographic & clinical criteria of the patients (p < 0.001). According to the univariate logistic regression analysis, a V/CrCl ratio >2.859 was a significant predictor of CIN (OR = 22.691, 95% CI 8.409–61.23, P < 0.001). In the multivariate analysis, a V/CrCl ratio of >2.859 (OR = 25.092, 95% CI 8.481–74.237, P < 0.001) remained an independent risk factor of CIN after adjusting for other potential risk factors (Tables 5 and 6 ). 5. Discussion The present study was performed to find the early predictor for detection and prevetion of CIN in our cath lab. The prevention of CIN in patients with relatively normal renal function is challaning during coronary intervention. In our study The early predictor of CIN is contrast volume to creatinine clearance ratio (V/CrCl ratio >2.85). In clinical practice, patients with elevated baseline Serum Cr should receive sufficient peri-procedural CIN prophylaxis, and early calculation of the safe contrast dye dose based on renal function before the procedure according to guidelines from the European Society of Cardiology9 the American College of Cardiology.10 However, in low risk patients for CIN with normal Serum Cr values donot receive any prophylactic measures for CIN. In many studies the patients with normal serum Cr was similar to patients with chronic renal impairement in developing CIN post cardiac catherization with similar poor prognosis.11 In another study the increase in 0.5 mg/dl of serum creatinine was an independent predictor of in-hospital cardiac events in patients with normal renal function.12 A large contrast media volume is a early contributor to CIN in patients with normal renal function, 11
sex Smoking DM HTN Prem.CAD dyslipidemia
Female Male yes no yes no yes no yes no yes no
no
Count
%
Count
%
10 24 11 23 21 13 28 6 3 31 15 19
29.4% 70.6% 32.4% 67.6% 61.8% 38.2% 82.4% 17.6% 8.8% 91.2% 44.1% 55.9%
79 201 125 155 116 164 136 144 34 246 62 218
28.2% 71.8% 44.6% 55.4% 41.4% 58.6% 48.6% 51.4% 12.1% 87.9% 22.1% 77.9%
0.884 0.172 0.024 < 0.001 0.780 0.005
and a reduction in contrast media volume has been reported to be a possible means for preventing CIN. Therefore, determining the safe contrast media volume is important for preventing CIN. Several cut off values for safe contrast media volume have been reported. The V/CrCl ratio represents the contrast media dose and renal function. This index can predict the safety profile of contrast dye than the absolute contrast volume alone.13 The V/CrCl ratio is applicable method for determining the maximum safe contrast volume and is a predictor of CIN following cardiac catheterization. Another study observed that a V/CrCl ratio >3.7 demonstrated the optimal sensitivity and specificity for detecting CIN, and it is an independent predictor for CIN.14 Our study demonstrated that the V/CrCl ratio of >2.859 remained an independent risk factor of CIN after adjusting for other potential risk factors. Another study had reported that the cut off value for the V/CrCl ratio was2.60 in patients with diabetes mellitus undergoing elective PCI which is in accordance with our study result.15 About 1020 patients with normal renal function were enrolled in one study the age of patients >65 years with (baseline serum creatinine <1.5 mg/dl) undergoing PCI. Receiver operating characteristic (ROC) curves were used to identify the optimal cut off value of V/CrCl for detecting CIN. Thirty-nine patients (3.8%) developed CIN. There was a significant association between a higher V/CrCl ratio and CIN risk (P < 0.001). ROC curve analysis indicated that a V/CrCl ratio of 2.74 was a fair discriminator for CIN (C statistic = 0.68). After adjusting for other known CIN risk factors, V/CrCl ratios >2.74 remained significantly associated with CIN (odds ratio = 3.21, 95% confidence interval [CI] 1.45–7.09, P = 0.004). 16 However, the present study demonstrated the optimal cut off value for the V/CrCl ratio (2.85) in patients with relatively normal renal function
Table 1 Demographic and clinical criteria of the patients with or without CIN. P value
CIN yes
age body Wt. Volume of dye SBP DBP Cr before urea before Cr.Cl.before S.creat after S.urea after Cr.Cl after V/Cr.Cl before
no
Mean
SD
Median
Minimum
Maximum
Mean
SD
Median
Minimum
Maximum
59.41 78.82 285.59 140.59 81.76 1.38 34.24 65.96 2.56 62.53 39.72 4.93
9.99 9.46 94.68 34.37 9.04 .38 13.04 24.54 .98 44.05 22.12 2.46
60.00 77.50 300.00 130.00 80.00 1.60 32.00 58.20 2.30 44.00 35.25 4.60
35.00 70.00 130.00 100.00 70.00 .70 15.00 40.68 .70 20.00 14.37 1.33
84.00 110.00 500.00 250.00 100.00 1.80 78.00 128.00 4.60 158.00 113.43 11.26
54.08 80.38 152.00 128.14 79.86 .99 26.71 99.14 .97 27.26 100.50 1.82
9.54 11.79 89.86 15.80 9.78 .25 7.34 31.31 .25 6.78 31.17 1.44
53.00 80.00 135.00 130.00 80.00 1.00 26.00 96.28 .90 26.00 96.65 1.30
32.00 60.00 50.00 90.00 60.00 .47 12.00 25.76 .60 15.00 26.40 .27
84.00 140.00 500.00 180.00 100.00 2.20 57.30 189.90 2.00 55.00 215.78 10.91
0.002 0.574 <0.001 0.037 0.278 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
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Table 3 Baseline Characteristics of the V/ CrCl Ratio Quartiles. V/CrCl Quartiles
P value
Q1
age body Wt. Volume of dye SBP DBP S.creat before S.urea before Cr.Cl.before S.creat after S.urea after Cr.Cl after
Q2
Q3
Q4
Mean
SD
Mean
SD
Mean
SD
Mean
SD
50.71 89.61 65.84 136.10 85.06 .85 26.89 129.01 .84 27.81 129.65
7.58 13.82 7.88 14.23 9.55 .15 7.15 28.41 .13 6.27 30.53
53.24 80.49 107.47 131.14 79.37 1.00 26.84 100.32 1.01 27.73 98.49
7.53 9.51 39.07 23.92 8.33 .20 8.51 24.21 .28 9.41 23.51
54.95 75.44 205.51 122.69 78.08 .99 25.29 89.12 1.07 29.23 84.35
10.63 7.44 50.37 14.56 8.80 .23 5.05 19.96 .44 18.66 22.03
59.57 75.55 283.50 128.12 77.88 1.30 31.00 64.91 1.62 39.32 64.33
10.52 8.49 79.65 19.36 10.40 .35 10.94 16.92 .98 29.86 29.92
< < < < < < < < < < <
0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001
Table 4 Baseline clinical features of the V/ CrCl Ratio Quartiles. V/CrCl Quartiles
P value Q2
Q1
sex presentation
Smoking DM HTN Prem.CAD dyslipidemic Echo
age
Female Male chest pain Dyspnea epigastric pain yes no yes no yes no yes no yes no Positive for ishaemia RHD Negativefor ishaemia less than 50 years more than 50 years
P value
OR
Age >50 years VCrCl>2.8593 Smoking DM HTN Multi vessel disease Dyslipidemia
0.042 < 0.001 0.176 0.027 0.001 0.201 0.006
2.459 22.691 0.593 2.284 4.941 1.593 2.776
Q4
Count
%
Count
%
Count
%
Count
%
28 49 71 4 2 25 52 22 55 45 32 7 70 16 61 49 8 20 45 32
36.4% 63.6% 92.2% 5.2% 2.6% 32.5% 67.5% 28.6% 71.4% 58.4% 41.6% 9.1% 90.9% 20.8% 79.2% 63.6% 10.4% 26.0% 58.4% 41.6%
13 66 70 5 4 43 36 40 39 33 46 13 66 16 63 36 2 41 27 52
16.5% 83.5% 88.6% 6.3% 5.1% 54.4% 45.6% 50.6% 49.4% 41.8% 58.2% 16.5% 83.5% 20.3% 79.7% 45.6% 2.5% 51.9% 34.2% 65.8%
22 56 63 10 5 40 38 36 42 37 41 13 65 24 54 40 2 36 25 53
28.2% 71.8% 80.8% 12.8% 6.4% 51.3% 48.7% 46.2% 53.8% 47.4% 52.6% 16.7% 83.3% 30.8% 69.2% 51.3% 2.6% 46.2% 32.1% 67.9%
26 54 68 4 8 28 52 39 41 49 31 4 76 21 59 45 0 35 19 61
32.5% 67.5% 85.0% 5.0% 10.0% 35.0% 65.0% 48.8% 51.2% 61.2% 38.8% 5.0% 95.0% 26.2% 73.8% 56.2% .0% 43.8% 23.8% 76.2%
Table 5 Univariate logistic regression analysis to detect independent predictors of CIN. Variables
Q3
95.0% C.I. Lower
Upper
1.035 8.409 0.278 1.099 1.984 0.780 1.333
5.841 61.23 1.263 4.746 12.304 3.252 5.780
undergoing coronary intervention either diagnostic or PCI. The difference in cut off values for the V/CrCl ratio can be explained by the use of different timing for measuring serum Cr post coronary interventions (48–72 h or 24 h) and the different types of patients with chronic kidney disease, STEMI, and DM. It is known that Mehran score was used for CIN evaluation only after dye exposure.2 The Mehran risk score is the most widely used and classic model for CIN,and it has clinical and procedural factors, including age >75years, dye volume,and the presence of chronic heart failure, hypotension, anemia, DM and chronic kideny disease.
0.035 0.231
0.008 0.021 0.046 0.057 0.371 0.001
< 0.001
The best cut off value for the V/CrCl ratio plays an important role in calculating the safe dye dose for preventing of the CIN before the procedure and the early dectection of CIN post cardiac catherization.The direct toxicity by contrast media can lead to apoptosis and cell death of both endothelial and tubular cells, and could be related to harmful effects of free radicals and oxidative stress, resulting in the development of CIN.17 There is, a general agreement of using the small contrast media volume and the avoidance of repetitive coronary intervention. This represents one of the most important recommendations to prevent contrastassociated nephrotoxicity. (This is the defention of low dose Table 6 Multivariate logistic regression analysis to detect independent predictors of CIN. Variables
Age >50 years VCrCl>2.8593 Smoking DM HTN Multi vessel disease Dyslipidemia
P value
.393 <0.001 .659 .241 .035 .054 .013
OR
1.629 25.092 1.247 1.742 3.199 2.452 3.539
95.0% C.I. Lower
Upper
.532 8.481 .468 .689 1.084 .983 1.311
4.989 74.237 3.320 4.409 9.442 6.116 9.554
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W.A. Khalil et al. / Journal of Indian College of Cardiology xxx (2018) xxx–xxx
contrast media) : A low dose of contrast media was defined as <70 ml, <125 ml or <5 ml/kg (to a maximum of 300 ml), divided by the plasma creatinine concentration and (IF we are using low dose contrast media less than 100 ml there were no patients requring dialysis) there were no patients who received <100 ml of contrast dye required dialysis after low dose contrast media exposure.18 Briguori et al was In agreement with us who found a positive correlation between the volume of dye and the creatinine concentration.19
2.
3. 4.
5.
6. Conclusion A reduction in the contrast media volume to a V/CrCl ratio <2.85 is a new predictors for early diagnosis and prevention of CIN post cardiac catheterization in patients with relatively normal renal function.
6.
7. 8.
6.1. Recommendation This index (V/CrCl ratio) may be applied to calculate the safe volume of contrast media that used during coronary intervention without increasing the risk of CIN in normal renal function patients and if this index is >2.85 early post coronary procedure we can start early management of CIN without delay to 72 h. 6.2. Limitations Small number of patients groups and single centre study.
9.
10.
11.
12.
Disclosure statement 13.
The authors declare no conflicts of interest. 14.
Financial disclosures The authors declare no grants or funding supports or nonfinancial supports were given to this research.
15.
Acknowledgements
16.
To all patients and staff of cardiology department & cath lab for participation in this research work and starting a prevention program for contrast induced nephropathy in catheterization lab.
17. 18.
References 19. 1. Worasuwannarak S, Pornratanarangsi S. Prediction of contrast-induced nephropathy in diabetic patients undergoing elective cardiac catheterization or PCI: role of volume-to-creatinine clearance ratio and iodine
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Please cite this article in press as: W.A. Khalil, et al., The early detection and prevention of contrast induced nephropathy post coronary intervention in catheterization unit, J Indian Coll Cardiol. (2018), https://doi.org/10.1016/j.jicc.2018.10.001