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PP248-SUN EVALUATION OF PHYSICAL STABILITY OF TOTAL PARENTERAL NUTRITION ADMIXTURES FOR PEDIATRIC HOME CARE
Nutritional techniques and formulations I by nutritional centers, but general practitioners. The aim of the study was to analyze clinical value of HEN. Methods: A group of 227 (94 F, 133 M, 131 adults, 96 children, mean age 38.9) patients treated for at least 12 months at one HEN center was analyzed. To evaluate treatment outcome anthropometric and laboratory data were analyzed at the beginning and after 12 months of the treatment. To assess hospitalization’s rate and its length a 12-month period before HEN was checked. Results: The incidence of hospitalization fell from 423/year (1.86/patient/year) to 305/year (1.34/patient/year), while the mean length of hospital stay fell from 45.15 days/year down to 12.3/year (p < 0.05). Weight gain was observed in 202 patients (88.9%), weight loss in 4 (1.7%), the rest demonstrated no changes (n = 21, 9.2%). Red blood count and hemoglobin concentration increased in 154 (67.8%), decreased in 48 (21.1%) and remained unchanged in 25 (11%) of patients. Albumin concentration increased only in 86 (37.8%), while in 108 (47.5%) decreased or remain stable (n = 33, 14.5%). Liver tests normalized in all patients (n = 5) in whom they were abnormal at the beginning. Conclusion: HEN represents a very efficient treatment option, which allows to reduce hospital stay and the need of hospitalization, even if its effects are not evident during laboratory tests. Disclosure of Interest: None Declared.
PP248-SUN EVALUATION OF PHYSICAL STABILITY OF TOTAL PARENTERAL NUTRITION ADMIXTURES FOR PEDIATRIC HOME CARE D. Wa˛tr´ obska-´ Swietlikowska1 , A. Szlagatys-Sidorkiewicz2 , M. Sznitowska1 . 1 Department of Pharmaceutical Technology, 2 Dept. of Pediatrics, Gastroenterology, Hepatology, Medical University of Gdansk, Gdansk, Poland Rationale: The aim of this study was to evaluate physical stability of 18 TPN home admixtures for pediatric patients. Four types of lipid emulsions Omegaven, Intralipid, Lipofundin LCT/MCT and SMOFlipid were used for preparation of TPN admixtures. Methods: TPN pre-admixtures were prepared in twochamber EVA bags, where lipid emulsion was placed separately from others components in the second chamber. Vitamin preparations were added only after combing the contents of two chambers of bag. TPN pre-admixtures were storage up to 21 days at +4ºC. Physical analysis: visual observations, globule size distribution (optical microscopy and laser diffractometry) and pH analysis were performed after admixing all components, together with vitamins and after storage for 24 h at 21ºC. Results: Visual observations of all complete admixtures did not reveal any changes after 24 h of storage at +21ºC. In microscopic observation all TPN admixtures were characterized by size of oily globules not larger than 1 mm, which is safe for a patient. Using laser diffractometry the median (d0.5 ) of oily droplets in TPN admixtures was 310 330 nm and 90% of oily droplets (d0.9 ) were under 580 620 nm and no oily globules larger than 1 mm were detected. Oily droplets size distribution
123 remained unchanged after storage. The pH values of TPN admixtures were in range 6.02 6.52 and did not change during storage. Conclusion: It was noticed that TPN pre-admixtures might be storage for at least 21 days at 4ºC and complete admixtures demonstrated stability for at least 24 h at room temperature. Type of the lipid emulsion has no influence on stability of investigated admixtures. Disclosure of Interest: None Declared.
PP249-SUN RESULTS OF RANDOMIZED CONTROLLED CLINICAL STUDY EVALUATING EFFICACY AND SAFETY OF NEW ENTERAL NUTRITION PRODUCT ENG-J AFTER SURGERY FOR ESOPHAGEAL AND GASTRIC CANCER IN JAPAN R. Fukushima1 . 1 Surgery, Teikyo University School of Medicine, Tokyo, Japan Rationale: ENG-J is a new enteral nutrition product for Japan developed by Abbott Laboratories. This is the first ethical product that contains fructooligosaccharides, L-carnitine, taurine, selenium, molybdenum and chromium. The caloric density is 1.2 kcal/mL, and the amounts of copper, iron, zinc, manganese, calcium are also adjusted. We conducted a multi-center randomized open labeled clinical study comparing the efficacy and safety of this new formula with those of a commonly used standard formula in Japan (Racol). Methods: The subjects were 117 patients who underwent surgery for esophageal cancer or total gastrectomy for gastric cancer at 26 medical sites from September 2010 to August 2011. The patients were randomly assigned to receive either ENG-J (E group, n = 59) or Racol (R group, n = 58) via a tube. Both enteral formulae were initiated at 400 kcal/day with an infusion rate of less than 50 kcal/hour on postoperative day (POD) 3, gradually increased to the target dose of 25 35 kcal/kg/day on POD 7, and continued to POD 13. Nutritional status including blood concentrations of RTPs (rapid turnover proteins), adverse events and side effects were examined. The fecal output was evaluated using King’s Stool Chart. Results: The time course of changes in blood concentrations of RTPs, prognostic nutritional index and the incidence of adverse events and side effects were not different between the groups during the study period. Blood level of selenium (mg/L) in E group differed from that in R group on POD 13 (131.7±31.9 vs 112.9±28.4, p = 0.001). Mean King’s Stool score in E group was significantly lower than that in R group on POD 4 (1.8±4.5 vs 6.3±12.0, p = 0.009). Conclusion: ENG-J had equivalent nutritional efficacy and safety profile to those of the standard formula. It seemed that favorable fecal output was achieved with ENG-J after surgery. Disclosure of Interest: R. Fukushima Grant/Research Support from: This study was supported by Abbott Laboratories Japan.
PP248-SUN EVALUATION OF PHYSICAL STABILITY OF TOTAL PARENTERAL NUTRITION ADMIXTURES FOR PEDIATRIC HOME CARE D. Wa˛tr´ obska-´ Swietlikowska1 , A. Szlagatys-Sidorkiewicz2 , M. Sznitowska1 . 1 Department of Pharmaceutical Technology, 2 Dept. of Pediatrics, Gastroenterology, Hepatology, Medical University of Gdansk, Gdansk, Poland Rationale: The aim of this study was to evaluate physical stability of 18 TPN home admixtures for pediatric patients. Four types of lipid emulsions Omegaven, Intralipid, Lipofundin LCT/MCT and SMOFlipid were used for preparation of TPN admixtures. Methods: TPN pre-admixtures were prepared in twochamber EVA bags, where lipid emulsion was placed separately from others components in the second chamber. Vitamin preparations were added only after combing the contents of two chambers of bag. TPN pre-admixtures were storage up to 21 days at +4ºC. Physical analysis: visual observations, globule size distribution (optical microscopy and laser diffractometry) and pH analysis were performed after admixing all components, together with vitamins and after storage for 24 h at 21ºC. Results: Visual observations of all complete admixtures did not reveal any changes after 24 h of storage at +21ºC. In microscopic observation all TPN admixtures were characterized by size of oily globules not larger than 1 mm, which is safe for a patient. Using laser diffractometry the median (d0.5 ) of oily droplets in TPN admixtures was 310 330 nm and 90% of oily droplets (d0.9 ) were under 580 620 nm and no oily globules larger than 1 mm were detected. Oily droplets size distribution
123 remained unchanged after storage. The pH values of TPN admixtures were in range 6.02 6.52 and did not change during storage. Conclusion: It was noticed that TPN pre-admixtures might be storage for at least 21 days at 4ºC and complete admixtures demonstrated stability for at least 24 h at room temperature. Type of the lipid emulsion has no influence on stability of investigated admixtures. Disclosure of Interest: None Declared.
PP249-SUN RESULTS OF RANDOMIZED CONTROLLED CLINICAL STUDY EVALUATING EFFICACY AND SAFETY OF NEW ENTERAL NUTRITION PRODUCT ENG-J AFTER SURGERY FOR ESOPHAGEAL AND GASTRIC CANCER IN JAPAN R. Fukushima1 . 1 Surgery, Teikyo University School of Medicine, Tokyo, Japan Rationale: ENG-J is a new enteral nutrition product for Japan developed by Abbott Laboratories. This is the first ethical product that contains fructooligosaccharides, L-carnitine, taurine, selenium, molybdenum and chromium. The caloric density is 1.2 kcal/mL, and the amounts of copper, iron, zinc, manganese, calcium are also adjusted. We conducted a multi-center randomized open labeled clinical study comparing the efficacy and safety of this new formula with those of a commonly used standard formula in Japan (Racol). Methods: The subjects were 117 patients who underwent surgery for esophageal cancer or total gastrectomy for gastric cancer at 26 medical sites from September 2010 to August 2011. The patients were randomly assigned to receive either ENG-J (E group, n = 59) or Racol (R group, n = 58) via a tube. Both enteral formulae were initiated at 400 kcal/day with an infusion rate of less than 50 kcal/hour on postoperative day (POD) 3, gradually increased to the target dose of 25 35 kcal/kg/day on POD 7, and continued to POD 13. Nutritional status including blood concentrations of RTPs (rapid turnover proteins), adverse events and side effects were examined. The fecal output was evaluated using King’s Stool Chart. Results: The time course of changes in blood concentrations of RTPs, prognostic nutritional index and the incidence of adverse events and side effects were not different between the groups during the study period. Blood level of selenium (mg/L) in E group differed from that in R group on POD 13 (131.7±31.9 vs 112.9±28.4, p = 0.001). Mean King’s Stool score in E group was significantly lower than that in R group on POD 4 (1.8±4.5 vs 6.3±12.0, p = 0.009). Conclusion: ENG-J had equivalent nutritional efficacy and safety profile to those of the standard formula. It seemed that favorable fecal output was achieved with ENG-J after surgery. Disclosure of Interest: R. Fukushima Grant/Research Support from: This study was supported by Abbott Laboratories Japan.