Journal of Critical Care 31 (2016) 201–205
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Decreasing maintenance fluids in normotensive trauma patients may reduce intensive care unit stay and ventilator days☆,☆☆,★ Galinos Barmparas, MD, Ara Ko, MD, Megan Y. Harada, BA, Andrea A. Zaw, MD, Jason S. Murry, MD, Eric J.T. Smith, BA, Sogol Ashrafian, BS, Beatrice J. Sun, BS, Eric J. Ley, MD ⁎ Division of Trauma and Critical Care, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA
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Keywords: Fluid resuscitation To keep open Normotensive Maintenance fluid rate Fluid balance
a b s t r a c t Purpose: The purpose of the study is to determine if excessive fluid administration is associated with a prolonged hospital course and worse outcomes. Materials and methods: In July 2013, all normotensive trauma patients admitted to the surgical intensive care unit (ICU) were administered crystalloids at 30 mL/h (“to keep open [TKO]”) and were compared to patients admitted during the preceding 6 months who were placed on a rate between 125 mL/h to 150 mL/h (non-TKO). The primary outcomes were ICU, hospital, and ventilator days. Results: A total of 101 trauma patients met inclusion criteria: 56 (55.4%) in the TKO and 45 (44.6%) in the nonTKO group. Overall, the 2 groups were similar in regard to age, Injury Severity Score, Acute Physiology and Chronic Health Evaluation IV scores, and the need for mechanical ventilation. TKO had no effect on renal function compared to non-TKO with similarities in maximum hospital creatinine. TKO patients had lower ICU stay (2.7 ± 1.5 vs 4.1 ± 4.6 days; P = .03) and ventilator days (1.4 ± 0.5 vs 5.5 ± 4.8 days; P b .01). Conclusions: A protocol that encourages admission basal fluid rate of TKO or 30 mL/h in normotensive trauma patients is safe, reduces fluid intake, and may be associated with a shorter intensive care unit course and fewer ventilator days. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Holiday and Segar in 1957 provided guidance on the maintenance crystalloid required for hospitalized patients based upon caloric expenditure, insensible loss, and renal loss [1]. Current guidelines are based upon their work such that maintenance intravenous fluids are commonly set between 125 and 150 mL/h. Trauma patients receive large volumes of crystalloid resuscitation beginning in the emergency department, and this continues through the intensive care unit (ICU) such that maintenance fluids, boluses, and piggyback riders combined can exceed four liters a day [2-4]. The deleterious effects of large volume resuscitation have received increased attention [5-7]. These studies challenged ☆ The abstract for this manuscript was a poster presentation at the 73rd meeting of the Annual Meeting of AAST and Clinical Congress of Acute Care Surgery, Philadelphia, PA, on September 10 to 13, 2014. ☆☆ The authors have no conflict of interest to report and have received no financial or material support related to this manuscript. ★ Subject category: Trauma. ⁎ Corresponding author at: Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Suite 8215N, Los Angeles, CA 90048. Tel.: +1 310 423 5874; fax: +1 310 423 0139. E-mail addresses:
[email protected] (G. Barmparas),
[email protected] (A. Ko),
[email protected] (M.Y. Harada),
[email protected] (A.A. Zaw),
[email protected] (J.S. Murry),
[email protected] (E.J.T. Smith), Sogol.ashrafi
[email protected] (S. Ashrafian),
[email protected] (B.J. Sun),
[email protected] (E.J. Ley). http://dx.doi.org/10.1016/j.jcrc.2015.09.030 0883-9441/© 2015 Elsevier Inc. All rights reserved.
the traditional resuscitation volumes recommended for trauma patients as large volumes of crystalloid were associated with increased mortality, morbidity, and hospital stay. Ventilator days and ICU complications are elevated with higher volume resuscitation, as are risk of abdominal compartment syndrome and coagulopathy [5,6,8-11]. Despite strong evidence in favor of reducing resuscitation volumes after trauma, maintenance fluids for normotensive trauma patients persist at 125 to 150 mL/h. Because of the concern for acute kidney injury, maintenance fluid rate often remains unchanged in the face of smaller volume resuscitation. However, patients who develop acute kidney injury show no benefit with higher crystalloid intake [9,12]. Clinical markers of adequate intravascular volume status, such as urine output and central venous pressure, often encourage higher volume maintenance fluids. However, these measures are unreliable gauges of volume status [13]. The correct rate of maintenance fluid in trauma patients has yet to be determined. We, therefore, focused on normotensive trauma patients admitted to the surgical ICU and provided a minimum basal fluid rate of “to keep open (TKO)” to determine whether reducing maintenance intravenous fluid would be safe and/or affect outcomes. 2. Materials and methods This study was conducted in a 24-bed dedicated surgical/trauma ICU at a level I trauma center. Trauma patients who were hemodynamically
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stable from admission and throughout their ICU stay were included. Hemodynamic stability or “normotension” was based on the fact that the patient's hemodynamics never dictated a decision to administer more than 2 consecutive liters of crystalloids or more than 2 consecutive units of packed red blood cells at once. There was no arbitrary value of blood pressure at any point from admission that was used for the purposes of this definition, and patients were excluded from the “normotensive” group based on the resuscitative efforts made on admission by the trauma surgeon and the intensivist indicating possible presence of hemodynamic instability. Data were collected prospectively for all trauma patients admitted to the surgical ICU from January 2013 to December 2013. On July 1, 2013, all normotensive trauma patients admitted to the surgical ICU were administered maintenance crystalloid fluids at 30 mL/h (TKO). We then compared TKO patients to those admitted to the surgical ICU in the preceding 6 months (non-TKO) who received a standard rate of crystalloids at 60 mL + 1 mL/kg over 20 kg or in general between 125 and 150 mL/h. Actual rate of maintenance and boluses were at the discretion of the surgical intensivist for the entire 12month period. Exclusions included initiation of vasopressors, brain death, and any surgical intervention. Primary outcomes included ICU and hospital length of stay (LOS) as well as number of ventilator days. Demographics and clinical data were abstracted from the patient charts on a daily basis by a dedicated research staff using a comprehensive data collection sheet. Data acquired included age, sex, mechanism of injury, Abbreviated Injury Scale (AIS) score, Injury Severity Score (ISS), Acute Physiology and Chronic Health Evaluation (APACHE) IV score, ICU and hospital LOS, and ventilator days. Daily and cumulative fluid balances were collected until the day of ICU transfer or until ICU day 5, whichever occurred first. Total intake included maintenance fluids, drips, intravenous medications, and oral intake. TKO and nonTKO cohorts were compared using the Pearson χ2 or Fisher exact test for categorical variables and the Student t test or Mann-Whitney U test for continuous variables, depending on skewness and kurtosis of each variable as markers of normal distribution. Statistical significance was defined as a P b .05. Institutional review board approval was obtained before conduction of the study. 3. Results During the 1-year study period, 202 trauma patients were admitted to the surgical ICU (Fig. 1). Surgical interventions occurred in 82 patients, vasopressors were used in 16 (7 in the non-TKO and 9 in the
TKO group), whereas 3 patients were declared brain dead. For the remaining 101 patients who were included, the mean age was 51.9 ± 23.8 years, 76.2% were male, and 33.7% were mechanically ventilated (Table 1). Patients were evenly divided with 56 TKO (55.4%) and 45 non-TKO (44.6%). TKO patients were similar to non-TKO in regard to age (51.6 ± 25.2 vs 52.2 ± 22.1 years, P = .90), ISS (12.5 ± 9.6 vs 12.9 ± 8.9; P = .79), head AIS greater than or equal to 3 (33.9% vs 37.8%; P = .69), APACHE IV scores (34.8 ± 28.1 vs 38.3 ± 28.8; P = .55), and the need for mechanical ventilation (37.5% vs 28.9%; P = .36) (Table 1). Most patients had a concomitant morbidity before admission, and no differences were observed between the 2 cohorts (Table 2). Type of injury was also similar between TKO and non-TKO (Table 3). Although cumulative volume intake for TKO was less than that of non-TKO (4605 ± 3714 vs 6495 ± 5076 mL; P = .03), the total intake for the first 48 hours and average fluid intake per day did not reach significance (Table 4). The 2 groups were similar in the total volume of boluses received during their ICU stay (763 ± 1061 mL TKO vs 767 ± 1313 mL non-TKO; P = .99). Cumulative urine output was lower in TKO (3362 ± 2615 mL vs 4722 ± 3901 mL; P = .04), and average daily urine output was similar. The lower net cumulative fluid balance in TKO patients did not reach significance (983 ± 2484 mL vs 1794 ± 2924 mL; P = .14). TKO had no effect on renal function compared to non-TKO, with similarities in maximum hospital creatinine (1.2 ± 0.9 vs 1.2 ± 0.7 mg/dL; P = .94) and creatinine elevation by 1.5 times (3.6% vs 4.4%; P = 1.00) (Table 4). Outcome differences reached significance when the cohorts were compared (Table 5). TKO patients had a shorter ICU stay (2.7 ± 1.5 vs 4.1 ± 4.6 days; P = .03) and were more likely to require an ICU stay less than 72 hours (83.9% vs 64.4%; P = .02). The number of ventilator days was also lower in TKO patients (1.4 ± 0.5 vs 5.5 ± 4.8 days; P b .01), although the reduction in hospital LOS did not reach significance (6.5 ± 6.1 vs 10.8 ± 16.3 days; P = .08). Only 1 patient in the nonTKO group died. 4. Discussion Given the efforts to reduce resuscitation volume after trauma, the appropriate rate for maintenance fluids requires attention. To our knowledge, this is the only data that demonstrates that normotensive trauma patients with maintenance fluid rate set at 30 mL/h have less cumulative crystalloid intake, reduced ICU stay, and reduced ventilator days without altering serum creatinine levels. Reducing the maintenance fluid rate may
Fig. 1. Study outline.
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Table 1 Comparison of basic demographics and injury characteristics between TKO and non-TKO patients
Age (y) N65 y Male Penetrating BMI (kg/m2) N30 ISS ≤16 17-25 N25 AIS Head ≥3 Chest ≥3 Abdomen/pelvis ≥3 Extremities ≥3 APACHE IVa N20a Mechanical ventilation Admission Cr (mg/dL) Mortality
Total (n = 101)
TKO (n = 56)
Non-TKO (n = 45)
P
51.9 ± 23.8 27.7% (28/101) 76.2% (77/101) 5.9% (6/101) 25.4 ± 4.9 [24.4] 11.9% (12/101) 12.7 ± 9.3 [11.0] 65.3% (66/101) 24.8% (25/101) 9.9% (10/101)
51.6 ± 25.2 30.4% (17/56) 80.4% (45/56) 5.4% (3/56) 25.8 ± 4.7 [25.0] 14.3% (8/56) 12.5 ± 9.6 [10.5] 62.5% (35/56) 28.6% (16/56) 8.9% (5/56)
52.2 ± 22.1 24.4% (11/45) 71.1% (32/45) 6.7% (3/45) 25.0 ± 5.2 [24.2] 8.9% (4/45) 12.9 ± 8.9 [11.0] 68.9% (31/45) 20.0% (9/45) 11.1% (5/45)
.900 .509 .278 1.000 .393 .405 .794 .502 .321 .748
35.6% (36/101) 22.8% (23/101) 7.9% (8/101) 12.9% (13/101) 36.3 ± 28.4 [29.6] 64.9% (63/97) 33.7% (34/101) 1.1 ± 0.5 [0.9] 0.01% (1/101)
33.9% (19/56) 23.2% (13/56) 7.1% (4/56) 12.5% (7/56) 34.8 ± 28.1 [25.5] 62.3% (33/53) 37.5% (21/56) 1.0 ± 0.6 [1.0] 0.0% (0/56)
37.8% (17/45) 22.2% (10/45) 8.9% (4/45) 13.3% (6/45) 38.3 ± 28.8 [33.2] 68.2% (30/44) 28.9% (13/45) 0.6 ± 0.4 [0.9] 0.02% (1/45)
.688 .906 1.000 .901 .546 .543 .363 .845 .262
P values were extracted from χ2 or Fisher exact test for categorical variables and t test or Mann-Whitney U test for continuous variables. Cr indicates creatinine. a A total of 4 patients had no APACHE IV score due to surgical ICU stay of less than 24 hours.
seem unnecessary, as changing this rate did not alter the average daily intake. However, the change to TKO made a difference as cumulative volume intake was almost 2 L lower, and more specifically, there was a trend toward a significant decrease in the intake by approximately 1.5 L in the first 48 hours, which was the ICU LOS for the majority of included patients. As may be expected, the cumulative urine output was higher in the non-TKO cohort, and because of urine output, the cumulative fluid balance was similar between groups. Our findings indicate that cumulative crystalloid intake may be as important as positive fluid balance and minimizing both, when possible, is indicated. Previously, we established the importance of a negative fluid balance after trauma [14], and this led to our efforts to reduce maintenance fluids. Many dogmas of volume resuscitation have been updated [57,15]. Initial volume resuscitation in the trauma bay no longer mandates a 2-L bolus [5]. Blood transfusions are sometimes favored over crystalloid during transport [16] or in the emergency department [17]. Minimizing both crystalloid and blood products likely reduces inflammation, immune dysfunction, ventilator dependence, and a number of other complications [18-25]. We chose to focus our study on trauma patients admitted to the ICU as these patients could both be closely monitored for signs of underresuscitation and would likely benefit from reduced crystalloid intake. While in the ICU, the decision to bolus patients was based upon a number of hemodynamic parameters, and the bolus volumes were
Table 2 Comparison of underlying comorbid conditions between TKO and non-TKO patients
Hypertension Cardiac history Stroke COPD Cancer DVT/PE Immunosuppression Diabetes mellitus Renal insufficiency Cirrhosis Alcohol abuse Illicit drug use
Total (n = 101)
TKO (n = 56)
Non-TKO (n = 45)
P
12.9% (13/101) 9.9% (10/101) 2.0% (2/101) 3.0% (3/101) 7.9% (8/101) 1.0% (1/101) 3.0% (3/101) 11.9% (12/101) 4.0% (4/101) 2.0% (2/101) 31.7% (32/101) 6.9% (7/101)
14.3% (8/56) 12.9% (8/62) 1.8% (1/56) 1.8% (1/56) 7.1% (4/56) 1.8% (1/56) 5.4% (3/56) 10.7% (6/56) 3.6% (2/56) 1.8% (1/56) 35.7% (20/56) 7.1% (4/56)
11.1% (5/45) 5.1% (2/39) 2.2% (1/45) 4.4% (2/45) 8.9% (4/45) 0.0% (0/45) 0.0% (0/45) 13.3% (6/45) 4.4% (2/45) 2.2% (1/45) 26.7% (12/45) 6.7% (3/45)
.636 .324 1.000 .584 1.000 1.000 .251 .686 1.000 1.000 .331 1.000
P values were extracted from χ2 or Fisher exact test. COPD indicates chronic obstructive pulmonary disease; DVT, deep venous thrombosis; PE, pulmonary embolism.
similar between cohorts. For the purposes of this study, only normotensive trauma patients admitted to the surgical ICU were provided crystalloid at the TKO rate. Currently and after verifying that the TKO strategy is safe and is associated with shortened ICU and hospital LOS, all trauma patients admitted to the floor and ICU are started at TKO. For unstable patients, we provide additional crystalloid by bolus or blood products while keeping the maintenance rate at TKO. One concern in critically ill trauma patients is acute kidney injury. Predictors of acute kidney injury after trauma include age, injury severity, lower Glasgow Coma Scale, shock, medications, and repeat administrations of intravenous contrast [26,27]. Higher creatinine often leads to fluid accumulation, oliguria, and increased fluid intake, which perpetuates the problem [9]. We demonstrated that a lower maintenance rate administered to critically injured trauma patients does not alter the rate of acute kidney injury. In addition, our analysis showed that reduced fluid intake might be associated with fewer ventilator days and shorter ICU LOS. In a previous study, less fluid intake was also associated with a decrease in adverse lung function [28]. Although we did not
Table 3 Comparison of traumatic injuries between TKO and non-TKO patients Total (n = 101) Facial bone fracture Base of skull fracture Vault of skull fracture Vertebral column fracture Rib/sternal fracture Pelvic fracture Clavicle fracture Scapular fracture Upper extremity fracture Lower extremity fracture Traumatic brain injury Hemothorax or pneumothorax Lung injurya Liver injury Splenic injury Kidney/other genitourinary injury
TKO (n = 56) Non-TKO (n = 45)
15.8% (16/101) 14.3% (8/56) 17.8% (8/45) 12.9% (13/101) 12.5% (7/56) 13.3% (6/45) 1.0% (1/101) 1.8% (1/56) 0.0% (0/45) 21.8% (22/101) 23.2% (13/56) 20.0% (9/45) 27.7% (28/101) 10.9% (11/101) 7.9% (8/101) 6.9% (7/101) 4.0% (4/101) 10.9% (11/101) 30.7% (31/101) 13.9% (14/101)
28.6% (16/56) 14.3% (8/56) 10.7% (6/56) 8.9% (5/56) 3.6% (2/56) 8.9% (5/56) 28.6% (16/56) 12.5% (7/56)
12.9% (13/101) 12.5% (7/56) 3.0% (3/101) 1.8% (1/56) 3.0% (3/101) 1.8% (1/56) 1.0% (1/101) 1.8% (1/56)
P values were extracted from χ2 or Fisher exact test. a Including pulmonary contusions.
P .633 .901 1.000 .697
26.7% (12/45) .832 6.7% (3/45) .337 4.4% (2/45) .293 4.4% (2/45) .457 4.4% (2/45) 1.000 13.3% (6/45) .533 33.3% (15/45) .606 15.6% (7/45) .659 13.3% (6/45) 4.4% (2/45) 4.4% (2/45) 0.0% (0/45)
.901 .584 .584 1.000
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Table 4 Comparison of fluid balance between TKO and non-TKO patients
Cumulative intake (mL) Average intake/day (mL/d) Total intake first 48 h (mL) Cumulative boluses received (mL) Total days boluses received Average urine output/day (mL/d) Cumulative urine output (mL) Days with negative fluid balance Cumulative fluid balance Max Cr during ICU stay (mg/dL) Max Cr during hospital stay (mg/dL) Admission Cr:Cr on day 5 ratio Cr increase × 1.5 during ICU stay Cr increase × 2.0 during ICU stay Cr increase × 3.0 during ICU stay
Total (n = 101)
TKO (n = 56)
Non-TKO (n = 45)
P
5447 ± 4451 [3986] 2414 ± 1608 [2162] 3874 ± 2602 [2978] 765 ± 1174 [250] 0.7 ± 0.8 [1.0] 1575 ± 824 [1483] 3968 ± 3305 [3191] 1.1 ± 0.9 [1.0] 1344 ± 2705 [672] 1.2 ± 0.7 [1.0] 1.2 ± 0.8 [1.0] 1.1 ± 0.2 [1.0] 4.0% (4/101) 0 0
4605 ± 3714 [3364] 2353 ± 1434 [2071] 3468 ± 2335 [2900] 763 ± 1061 [500] 0.7 ± 0.6 [1.0] 1534 ± 805 [1416] 3362 ± 2615 [2771] 1.0 ± 0.8 [1.0] 983 ± 2484 [567] 1.2 ± 0.9 [0.9] 1.2 ± 0.9 [0.9] 1.1 ± 0.1 [1.0] 3.6% (2/56) 0 0
6495 ± 5076 [5718] 2498 ± 1826 [2310] 4379 ± 2846 [4317] 767 ± 1313 [0] 0.7 ± 1.0 [0.0] 1632 ± 850 [1580] 4722 ± 3901 [3874] 1.2 ± 1.0 [1.0] 1794 ± 2924 [1220] 1.1 ± 0.4 [1.0] 1.2 ± 0.7 [1.0] 1.1 ± 0.2 [1.0] 4.4% (2/45) 0 0
.033 .547 .080 .989 .711 .343 .039 .296 .135 .647 .944 .688 1.000 N/A N/A
P values were extracted from χ2 or Fisher exact test for categorical variables and t test or Mann-Whitney U test for continuous variables. Cr indicates creatinine.
decrease the number of days that patients had a positive fluid balance or the cumulative net fluid balance, the lower crystalloid intake was likely beneficial. There are a number of limitations to this study. We followed patients in both cohorts for up to 5 days in the ICU, and this short stay may not have identified complications that occurred after day 5 or upon ICU transfer. We note that no patients required an unplanned return to the ICU. We did not identify mortality differences between the 2 cohorts as only 1 patient died in the non-TKO group. Hence, if there is a mortality benefit to TKO, further studies will be required. Other limitations include lack of key data such as central venous pressure, pulmonary artery wedge pressure, or ejection fraction. A fluid bolus was given at the discretion of the team based on the clinical status of the patient. The rate of 30 mL/h was chosen as TKO because this was the minimal rate allowed by hospital policy. We chose to have a maintenance rate rather than saline lock the peripheral intravenous lines to be certain that access was available in case of emergency. As soon as possible, TKO was discontinued. We collected creatinine values as a marker of renal function. However, estimated creatinine clearance might have been a better indicator. Nonetheless, given the shorter ICU stay and fewer ventilator days, one could assume that fluid restriction was unlikely to be associated with worsening renal function given that these patients met discharge criteria earlier than patients with nonrestrictive fluid administration strategy. In addition, blood pressure data were not tracked in our data set. Rather than using an arbitrary value for systolic blood pressure to define hemodynamic stability or normotension, we used fluid management decisions made on admission by the trauma surgeon and/or the intensivist. It is possible that patients were falsely deemed “normotensive” or even the opposite. Our sample size is limited. This, however, was the result of our decision to include a homogeneous group of hemodynamically stable trauma patients who did not require surgical interventions to eliminate bias and other factors affecting fluid balance that could not be controlled with our study design. Patients undergoing surgical interventions were excluded as their fluid intake in the operating room was determined by the practices of the various anesthesiologists and operating surgeons who were not part
of this study protocol. Lastly, these findings might not be generalizable to a young, severely injured patient population. Our study cohort was older, with comorbid conditions and a high incidence of blunt injury. This study identifies an opportunity for further analysis in patients with higher ISS who may be more critically ill. These limitations do not affect our aim, which was to determine whether lowering the amount of maintenance fluid in trauma patients is safe and whether it alters cumulative fluid intake and outcomes. 5. Conclusions In conclusion, trauma patients in the ICU do not require maintenance fluids at rates that are traditionally encouraged. A protocol that mandates admission basal fluid rate of TKO or 30 mL/h in normotensive trauma patients reduces fluid intake and may be associated with a shorter ICU stay and fewer ventilator days. Trauma centers should consider TKO for all normotensive trauma patients admitted to the ICU. References [1] Holliday MA, Segar WE. The maintenance need for water in parenteral fluid therapy. Pediatrics 1957;19:823–32. [2] Moore FA, McKinley BA, Moore EE. The next generation in shock resuscitation. Lancet 2004;363:1988–96. http://dx.doi.org/10.1016/S0140-6736(04)16415-5. [3] Santry HP, Alam HB. Fluid resuscitation: past, present, and the future. Shock 2010; 33:229–41. http://dx.doi.org/10.1097/SHK.0b013e3181c30f0c. [4] Rhee P, Koustova E, Alam HB. Searching for the optimal resuscitation method: recommendations for the initial fluid resuscitation of combat casualties. J Trauma 2003;54:S52–62. http://dx.doi.org/10.1097/01.TA.0000064507.80390.10. [5] Ley EJ, Clond MA, Srour MK, Barnajian M, Mirocha J, Margulies DR, et al. Emergency department crystalloid resuscitation of 1.5 L or more is associated with increased mortality in elderly and nonelderly trauma patients. J Trauma Inj Infect Crit Care 2011;70:398–400. http://dx.doi.org/10.1097/TA.0b013e318208f99b. [6] Kasotakis G, Sideris A, Yang Y, de Moya M, Alam H, King DR, et al. Aggressive early crystalloid resuscitation adversely affects outcomes in adult blunt trauma patients: an analysis of the Glue Grant database. J Trauma Acute Care Surg 2013;74: 1215–22. http://dx.doi.org/10.1097/TA.0b013e3182826e13. [7] Cotton BA, Reddy N, Hatch QM, LeFebvre E, Wade CE, Kozar RA, et al. Damage control resuscitation is associated with a reduction in resuscitation volumes and improvement in survival in 390 damage control laparotomy patients. Ann Surg 2011; 254. http://dx.doi.org/10.1097/SLA.0b013e318230089e.
Table 5 Comparison of LOS and ventilation days between TKO and non-TKO patients
ICU days ICU days ≤72 h ICU-free days Ventilation days Ventilator-free days Hospital days
Total (n = 101)
TKO (n = 56)
Non-TKO (n = 45)
Mean difference (95% CI)
P
3.3 ± 3.3 [2.0] 75.2% (76/101) 5.1 ± 10.8 [3.0] 3.0 ± 3.5 [2.0] 7.4 ± 14.2 [3.0] 8.4 ± 11.9 [6.0]
2.7 ± 1.5 [2.0] 83.9% (47/56) 3.9 ± 6.0 [3.0] 1.4 ± 0.5 [1.0] 6.1 ± 9.3 [3.0] 6.5 ± 6.1 [6.0]
4.1 ± 4.6 [3.0] 64.4% (29/45) 6.7 ± 14.7 [3.0] 5.5 ± 4.8 [5.0] 9.4 ± 20.0 [3.0] 10.8 ± 16.3 [6.0]
−1.4 (−2.7, −0.1) 2.9 (1.1, 7.4) −2.8 (−1.5, −2.2) −4.0 (−6.2, −1.9) −3.3 (−13.6, 7.0) −4.2 (−8.9, 0.4)
.030 .024 .195 .001 .275 .075
P values were extracted from χ2 or Fisher exact test for categorical variables and t test or Mann-Whitney U test for continuous variables. CI indicates confidence interval.
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