Randomized, Parallel Group, Phase III Study to Compare Safety and Efficacy of BFLUID with a Commercially Available Solution, NUTRIFLEX PERI, as a Control Product in Patients Undergoing Gastrectomy or Colectomy

开始日期2021-01-25

申办/合作机构

Otsuka Pharmaceutical India Private Ltd.

100 项与 L-亮氨酸/L-异亮氨酸/L-缬氨酸/L-赖氨酸盐酸盐/L-苏氨酸/L-色氨酸/L-蛋氨酸/乙酰半胱氨酸/L-苯丙氨酸/L-酪氨酸/L-精氨酸/L-组氨酸/L-丙氨酸/L-脯氨酸/L-丝氨酸/甘氨酸/L-天冬氨酸/L-谷氨酸/磷酸二钾/磷酸氢钠水合物/柠檬酸钠水合物/L-乳酸钠相关的临床结果

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100 项与 L-亮氨酸/L-异亮氨酸/L-缬氨酸/L-赖氨酸盐酸盐/L-苏氨酸/L-色氨酸/L-蛋氨酸/乙酰半胱氨酸/L-苯丙氨酸/L-酪氨酸/L-精氨酸/L-组氨酸/L-丙氨酸/L-脯氨酸/L-丝氨酸/甘氨酸/L-天冬氨酸/L-谷氨酸/磷酸二钾/磷酸氢钠水合物/柠檬酸钠水合物/L-乳酸钠相关的转化医学

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100 项与 L-亮氨酸/L-异亮氨酸/L-缬氨酸/L-赖氨酸盐酸盐/L-苏氨酸/L-色氨酸/L-蛋氨酸/乙酰半胱氨酸/L-苯丙氨酸/L-酪氨酸/L-精氨酸/L-组氨酸/L-丙氨酸/L-脯氨酸/L-丝氨酸/甘氨酸/L-天冬氨酸/L-谷氨酸/磷酸二钾/磷酸氢钠水合物/柠檬酸钠水合物/L-乳酸钠相关的专利（医药）

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项与 L-亮氨酸/L-异亮氨酸/L-缬氨酸/L-赖氨酸盐酸盐/L-苏氨酸/L-色氨酸/L-蛋氨酸/乙酰半胱氨酸/L-苯丙氨酸/L-酪氨酸/L-精氨酸/L-组氨酸/L-丙氨酸/L-脯氨酸/L-丝氨酸/甘氨酸/L-天冬氨酸/L-谷氨酸/磷酸二钾/磷酸氢钠水合物/柠檬酸钠水合物/L-乳酸钠相关的文献（医药）

2024-08-31·Indian Journal of Critical Care Medicine

Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy: A Phase III Indian Clinical Trial

Article

作者: BS, Madhu ; Raju, Kvvn ; Soni, Harshad ; Shah, Chetna ; Patel, Dignesh ; Goyal, Amit ; Shah, Rakshit ; Bhatt, Keyur ; Madhu, B S ; Pathak, Anand ; Pathak, Anand ; Raju, KVVN ; Voonna, Murali K ; Soni, Harshad

Aims and backgroundVarious types of parenteral nutritional products exist, each with specific formulations designed to meet the diverse nutritional needs of patient's post-abdominal surgery. Here, two different parenteral nutrition (PN) solutions BFLUID and NUTRIFLEX PERI are compared in terms of therapeutic efficacy and safety profile.Materials and methodsA prospective, multi-center, randomized, parallel-group, non-inferiority Phase III clinical trial compared two PN solutions namely BFLUID (N = 78) and NUTRIFLEX PERI (N = 72) in 150 patients undergoing gastrectomy or colectomy. Primary endpoints included length of hospital stay while secondary endpoints included assessment and comparison of length of ICU/HDU stay, assessment of incidents of infections and mortality, change in blood levels of vitamin B1, change in nutritional parameters, thrombophlebitis, pain at the injection site, and recording of adverse events (AEs).ResultsThere was no significant difference in terms of length of hospital stay, length of ICU/HDU stay as well as changes in nutritional parameters from baseline and change in blood levels of vitamin B1 from baseline. Both study groups exhibited comparability in terms of AEs, pain at the injection site, and the incidence of phlebitis. There was no significant difference in the number and severity of adverse events reported in both groups. Additionally, no signs of infection were observed in patients from either group.ConclusionThe trial successfully demonstrated the non-inferiority of BFLUID to NUTRIFLEX PERI. Moreover, the results indicated that PN enriched with high levels of branched-chain amino acids (BCAAs), essential amino acids (EAAs), and thiamine is both safe and efficacious for adult patients undergoing gastrectomy or colectomy.How to cite this articleGoyal A, Pathak A, BS Madhu, Soni H, Bhatt K, Raju KVVN, et al. Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy: A Phase III Indian Clinical Trial. Indian J Crit Care Med 2024;28(9):871-878.

2022-09-01·Biological and Pharmaceutical Bulletin

Classification of Skin Injury Risk Caused by Extravasation of Electrolyte Solutions or Infusions in a Rat Model

Article

作者: Shibata, Yuuka ; Uno, Hiromi ; Yokooji, Tomoharu ; Matsuo, Hiroaki ; Hide, Michihiro ; Tanaka, Maiko ; Taogoshi, Takanori

Cytotoxic agents are classified according to the severity of skin injury after extravasation. However, injuries caused by extravasation of noncytotoxic agents have not been sufficiently investigated, although the risk of extravasation is mentioned in medical safety information published by the Japan Council for Quality Health Care. Therefore, in this study, we focused on noncytotoxic electrolyte solutions and infusions and evaluated skin injuries during leakage using extravasation model rats. Rats were anesthetized and intradermally injected with 100 µL of an electrolyte solution or infusion. Injection lesions were macroscopically and histopathologically evaluated for extravasation injuries. Each electrolyte solution and infusion were classified into three categories (vesicants, irritants, and non-tissue-damaging agents) depending on the degree of skin injury. Similar to saline, 0.3% potassium chloride and 0.6% magnesium sulfate showed almost no injury, and 3% sodium chloride and BFLUID^® caused erythema and induration. Erythema, induration, and ulceration were observed with the following: 10% sodium chloride, 2% calcium chloride, 8.5% calcium gluconate, 12.3% magnesium sulfate, MAGSENT^®, FESIN^®, and Intralipos^®. The duration of damage with these agents was markedly prolonged. Electrolyte solutions and infusions can be classified into vesicants (10% sodium chloride, 2% calcium chloride, 8.5% calcium gluconate, 12.3% magnesium sulfate, MAGSENT^®, FESIN^®, and Intralipos^®), irritants (3% sodium chloride and BFLUID^®), and non-tissue-damaging agents (0.3% potassium chloride and 0.6% magnesium sulfate) according to their composition. The characteristic symptoms and severity of each drug extravasation revealed in this study will provide basic information for preparation of guidelines for treatment of extravasation.

2017-01-01·International Journal of Medical Sciences3区 · 医学

Water Soluble Vitamins Enhance the Growth of Microorganisms in Peripheral Parenteral Nutrition Solutions

3区 · 医学

ArticleOA

作者: Omotani, Sachiko ; Mukai, Junji ; Tani, Katsuji ; Nagai, Katsuhito ; Hatsuda, Yasutoshi ; Myotoku, Michiaki

Peripheral parenteral nutrition (PPN) solutions contain amino acids, glucose, and electrolytes, with or without some water soluble vitamins. Peripheral venous catheters are one of the causes of catheter related blood stream infection (CRBSI), which requires infection control. In Japan, PPN solutions have rarely been prepared under aseptic conditions. However, in recent years, the necessity of adding vitamins to infusions has been reported. Therefore, we investigated the effects of water soluble vitamins on growth of microorganisms in PPN solutions. AMINOFLUID^® (AF), BFLUID^® (BF), PARESAFE^® (PS) and PAREPLUS^® (PP) PPN solutions were used. Water soluble vitamins contained in PP were also used. Causative microorganisms of CRBSI were used. Staphylococcus epidermidis decreased after 24 hours or 48 hours in all solutions. On the other hand, Escherichia coli, Serratia marcescens, Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans increased, especially in PP. When each water soluble vitamin was added to BF and PS, growth of S. aureus was greater in solutions that contained nicotinamide than in solutions that contained other vitamins. As for C. albicans, they grew in all test solutions. C. albicans grew especially well in solutions that contained biotin. When commercial amino acids and glucose solutions with electrolytes are administered, in particular those containing multivitamins or water soluble vitamins, efforts to control infection must be taken to prevent proliferation of microorganisms.

100 项与 L-亮氨酸/L-异亮氨酸/L-缬氨酸/L-赖氨酸盐酸盐/L-苏氨酸/L-色氨酸/L-蛋氨酸/乙酰半胱氨酸/L-苯丙氨酸/L-酪氨酸/L-精氨酸/L-组氨酸/L-丙氨酸/L-脯氨酸/L-丝氨酸/甘氨酸/L-天冬氨酸/L-谷氨酸/磷酸二钾/磷酸氢钠水合物/柠檬酸钠水合物/L-乳酸钠相关的药物交易

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