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P.61 Filtration of lipid containing total parenteral nutrition (TPN) admixtures
LPS and vit E (20.5 + 9.6), vit C (22.6 + 5.4) and vit E (19.7 _+8.9).
rating 1.2 ~m (Gelman Sciences and Pall Biomedical), to determine the effect of the filters on the lipid emulsion globule size distribution, and to challenge the fungal retentive capacities of the filters with Candida albicans. Flow rates of between 100 and 200 ml.h-1 were used for some typical peripheral and central Allin-One TPN regimens. Method/Results: The maintenance of the preset flow rates during the delivery of the total volume of the admixtures was used as a measure of filterability, while the pressure upstream of the filters was monitored and in all cases showed no clinically significant changes. The globule size distributions of the lipid emulsions were determined by laser diffraction (Malvern Mastersizer®) on samples collected upstream and downstream of the filter, all samples were shown to be unchanged. Finally filtrates from inoculated TPN admixture delivered through the filters were tested for the presence of Candida albicans over a 24-hour period with the results shown below.
Conclusions: In this preliminary study, the statistically significant LPS-induced formation of NO was observed to be reduced in the presence of vitamins C and E.
P.60 Infusion phlebitis: tolerance osmolarity for peripheral venous endothelial cells in the rabbit T. Kuwahara, S. Asanami and S. Kubo Naruto Research Institute, Otsuka Pharmaceutical Factory, Inc., Naruto, Tokushima 772, Japan. Aims: There are various factors which cause phlebitis in peripheral parenteral nutrition (PPN), and one of the greatest risk factors is hyperosmolarity of nutrient solutions. The aims of this study were to determine the osmolarity that peripheral venous endothelial cells can tolerate and to clarify the relationship between the tolerance osmolarity and the duration of infusion. Methods: PPN solutions with different osmolarity (540-950 mOsm/kg), which were prepared to have no acidic effect, were infused to ear lateral veins of rabbits at 5-15ml/kg/h, and the veins (3-10 mm from the tip of catheter) were sampled 20-24 h after infusion and examined histopathologically. The loss of venous endothelial cells, a finding considered to directly reflect the irritability of the solution, was graded as: 0, no changes; 1, loss of endothelial cells in less than 1/3 of vein in cross-section; 2, from 1/3 to 2/3; and 3, more than 2/3. Then the phlebitic potential of infused solutions was evaluated according to the incidence (no. of rabbits with the change/no, of rabbits examined) and the mean grade (total grades/no, of rabbits examined). Results: After 6h of infusion, a solution with osmolarity of 949 mOsm/kg caused venous changes such as the loss of endothelial cells (4/5, 1.00), but a solution of 851 mOsm/kg did not (0/8, 0). After 12h of infusion, 764 mOsm/kg caused the change (5/6, 1.17), 710 mOsm/kg caused slight changes (2/6, 0.33),and 680 mOsm/kg scarcely caused any changes (1/6, 0.17). After 24 h of infusion, 645 and 565 mOsm/kg caused slight changes (4/6, 0.67 and 2/6, 0.33, respectively), but 540 mOsm/kg did not (0/4, 0). Next, 120ml/kg of 814 mOsm/kg solution was infused at 3 different rates: 24 h of infusion at 5 ml/kg/h caused the change in all rabbits (8/8, 1/50), 12h infusion at 10ml/kg/h also caused the change but at a lower incidence (5/8, 1.00), and 8h infusion at 15 ml/kg/h scarcely caused any changes (1/8, 0.13). Conclusion: These results suggest that the tolerance osmolarity of peripheral venous endothelial cells is about 850 mOsm/kg for 6h of infusion, 680 mOsm/kg for 12h of infusion, and 540 mOsm/kg for 24 h of infusion. Since the tolerance osmolarity is lower at longer duration of infusion, the hypertonic solution should be infused at as high a rate as possible, without reducing its bioavailability, to prevent phlebitis.
Filter
MinimumCandida challenge
Averagetotalnumber of recoveredorganisms
Pall Biomedical Gelman Sciences
6 x 108 CFUs 6 x 108 CFUs
0 CFUs 3.29 x 104-+2.46 × 104 CFUs
Conclusion: The results demonstrate that the filters do not impede the flow rate or influence the lipid emulsion globule size distribution, however the Pall filter shows total retention of Candida, whilst the Gelman filter does not. This may be due to differences in the pore size distribution of the two filters as was indicated by Bubble Point pressure tests carried out on the filters, where the Gelman filter readings were approximately 15-20% lower than those of the Pall filter indicating a broader pore size distribution.
References: [1] Puntis J.W.L et al. Arch Dis Childhood 1992; 67: 1475-1477. [2] Driscoll D.F. DICP 1990; 24: 296-303. [3] Food and Drug Association. Am J Hosp Pharm 1994; 51: 1427-1428.
P.62 Complications of percutaneous endoscopy gastrostomy M. Del Piano, F. Montino, F'. Occhipinti, F. Rossi, F. D'Andrea* and M. Brugnani* Gastroenterology Dept and *Clinical Nutrition Service, Ospedale Maggiore, Novara, Italy. Percutaneous Endoscopy Gastrostomy (PEG) is a simple, safe, cost effective, well accepted and reversible feeding route for enteral nutrition, but as invasive technique can have complications: the cumulative literature data suggest a morbility rate from 0 to 44% and a mortality rate from 0 to 5%. This wide difference is due to many factors such as different age of the studies, use of a prospective or retrospective method for data collection, duration of follow-up, different classification criteria. Subjects and methods: A prospective analysis was performed on 218 patients (118 M, 100 F; mean age 66.8 years, range 27-92) treated by PEG between July 1989 and February 1995. We divided complications into minor (requiring local care or replacement of PEG tube) and major (requiring laparotomy or lifethreatening) and subdivided them into transoperative (at the time of PEG placement), infective, mechanical (related to PEG use) and nutritional. Results: The success rate of technique was 98.1%; no procedure related mortality was observed. Majolr complication occurred in 2 patients (0.93%: 1 peritonitis, 1 massive gastric bleeding). Minor complications rate was 25.7%: skin infection (3.7%), pneumoperitoneum (1.4%), gastro-esophageal reflux (4.2%), hematoma (0.4%), mechanical problems (13%: 0.4% tube migration with out-
P.61 Filtration of lipid containing total parenteral nutrition (TPN) admixtures M. I. Barnett, A. G. Cosslett and J. Cohen Welsh School of Pharmacy, U.W.C.C., Cardiff, UK. Introduction: The clinical importance of the removal of particulate matter and bacteria has been shown by Puntis et al [1] and the clinical impact of the presence of fungal organisms such as Candida species has been reviewed by Driscoll [2]. The problems of particulate matter was further highlighted in 1994 by an FDA alert on the presence of precipitated materials in TPN admixtures containing lipid emulsions, which led to the FDA recommending the routine use of 1.2 pm end-line filters [3]. Aim of study: To investigate the filterability of TPN admixtures through two commercially available end-line filters of nominal pore 49
rating 1.2 ~m (Gelman Sciences and Pall Biomedical), to determine the effect of the filters on the lipid emulsion globule size distribution, and to challenge the fungal retentive capacities of the filters with Candida albicans. Flow rates of between 100 and 200 ml.h-1 were used for some typical peripheral and central Allin-One TPN regimens. Method/Results: The maintenance of the preset flow rates during the delivery of the total volume of the admixtures was used as a measure of filterability, while the pressure upstream of the filters was monitored and in all cases showed no clinically significant changes. The globule size distributions of the lipid emulsions were determined by laser diffraction (Malvern Mastersizer®) on samples collected upstream and downstream of the filter, all samples were shown to be unchanged. Finally filtrates from inoculated TPN admixture delivered through the filters were tested for the presence of Candida albicans over a 24-hour period with the results shown below.
Conclusions: In this preliminary study, the statistically significant LPS-induced formation of NO was observed to be reduced in the presence of vitamins C and E.
P.60 Infusion phlebitis: tolerance osmolarity for peripheral venous endothelial cells in the rabbit T. Kuwahara, S. Asanami and S. Kubo Naruto Research Institute, Otsuka Pharmaceutical Factory, Inc., Naruto, Tokushima 772, Japan. Aims: There are various factors which cause phlebitis in peripheral parenteral nutrition (PPN), and one of the greatest risk factors is hyperosmolarity of nutrient solutions. The aims of this study were to determine the osmolarity that peripheral venous endothelial cells can tolerate and to clarify the relationship between the tolerance osmolarity and the duration of infusion. Methods: PPN solutions with different osmolarity (540-950 mOsm/kg), which were prepared to have no acidic effect, were infused to ear lateral veins of rabbits at 5-15ml/kg/h, and the veins (3-10 mm from the tip of catheter) were sampled 20-24 h after infusion and examined histopathologically. The loss of venous endothelial cells, a finding considered to directly reflect the irritability of the solution, was graded as: 0, no changes; 1, loss of endothelial cells in less than 1/3 of vein in cross-section; 2, from 1/3 to 2/3; and 3, more than 2/3. Then the phlebitic potential of infused solutions was evaluated according to the incidence (no. of rabbits with the change/no, of rabbits examined) and the mean grade (total grades/no, of rabbits examined). Results: After 6h of infusion, a solution with osmolarity of 949 mOsm/kg caused venous changes such as the loss of endothelial cells (4/5, 1.00), but a solution of 851 mOsm/kg did not (0/8, 0). After 12h of infusion, 764 mOsm/kg caused the change (5/6, 1.17), 710 mOsm/kg caused slight changes (2/6, 0.33),and 680 mOsm/kg scarcely caused any changes (1/6, 0.17). After 24 h of infusion, 645 and 565 mOsm/kg caused slight changes (4/6, 0.67 and 2/6, 0.33, respectively), but 540 mOsm/kg did not (0/4, 0). Next, 120ml/kg of 814 mOsm/kg solution was infused at 3 different rates: 24 h of infusion at 5 ml/kg/h caused the change in all rabbits (8/8, 1/50), 12h infusion at 10ml/kg/h also caused the change but at a lower incidence (5/8, 1.00), and 8h infusion at 15 ml/kg/h scarcely caused any changes (1/8, 0.13). Conclusion: These results suggest that the tolerance osmolarity of peripheral venous endothelial cells is about 850 mOsm/kg for 6h of infusion, 680 mOsm/kg for 12h of infusion, and 540 mOsm/kg for 24 h of infusion. Since the tolerance osmolarity is lower at longer duration of infusion, the hypertonic solution should be infused at as high a rate as possible, without reducing its bioavailability, to prevent phlebitis.
Filter
MinimumCandida challenge
Averagetotalnumber of recoveredorganisms
Pall Biomedical Gelman Sciences
6 x 108 CFUs 6 x 108 CFUs
0 CFUs 3.29 x 104-+2.46 × 104 CFUs
Conclusion: The results demonstrate that the filters do not impede the flow rate or influence the lipid emulsion globule size distribution, however the Pall filter shows total retention of Candida, whilst the Gelman filter does not. This may be due to differences in the pore size distribution of the two filters as was indicated by Bubble Point pressure tests carried out on the filters, where the Gelman filter readings were approximately 15-20% lower than those of the Pall filter indicating a broader pore size distribution.
References: [1] Puntis J.W.L et al. Arch Dis Childhood 1992; 67: 1475-1477. [2] Driscoll D.F. DICP 1990; 24: 296-303. [3] Food and Drug Association. Am J Hosp Pharm 1994; 51: 1427-1428.
P.62 Complications of percutaneous endoscopy gastrostomy M. Del Piano, F. Montino, F'. Occhipinti, F. Rossi, F. D'Andrea* and M. Brugnani* Gastroenterology Dept and *Clinical Nutrition Service, Ospedale Maggiore, Novara, Italy. Percutaneous Endoscopy Gastrostomy (PEG) is a simple, safe, cost effective, well accepted and reversible feeding route for enteral nutrition, but as invasive technique can have complications: the cumulative literature data suggest a morbility rate from 0 to 44% and a mortality rate from 0 to 5%. This wide difference is due to many factors such as different age of the studies, use of a prospective or retrospective method for data collection, duration of follow-up, different classification criteria. Subjects and methods: A prospective analysis was performed on 218 patients (118 M, 100 F; mean age 66.8 years, range 27-92) treated by PEG between July 1989 and February 1995. We divided complications into minor (requiring local care or replacement of PEG tube) and major (requiring laparotomy or lifethreatening) and subdivided them into transoperative (at the time of PEG placement), infective, mechanical (related to PEG use) and nutritional. Results: The success rate of technique was 98.1%; no procedure related mortality was observed. Majolr complication occurred in 2 patients (0.93%: 1 peritonitis, 1 massive gastric bleeding). Minor complications rate was 25.7%: skin infection (3.7%), pneumoperitoneum (1.4%), gastro-esophageal reflux (4.2%), hematoma (0.4%), mechanical problems (13%: 0.4% tube migration with out-
P.61 Filtration of lipid containing total parenteral nutrition (TPN) admixtures M. I. Barnett, A. G. Cosslett and J. Cohen Welsh School of Pharmacy, U.W.C.C., Cardiff, UK. Introduction: The clinical importance of the removal of particulate matter and bacteria has been shown by Puntis et al [1] and the clinical impact of the presence of fungal organisms such as Candida species has been reviewed by Driscoll [2]. The problems of particulate matter was further highlighted in 1994 by an FDA alert on the presence of precipitated materials in TPN admixtures containing lipid emulsions, which led to the FDA recommending the routine use of 1.2 pm end-line filters [3]. Aim of study: To investigate the filterability of TPN admixtures through two commercially available end-line filters of nominal pore 49