Role of Peripheral Parenteral Nutrition Composition on Clinical Outcomes in Patients Undergoing Gastrectomy or Colectomy: A Phase III Indian Clinical Trial.
Amit Goyal, Anand Pathak, B S Madhu, Harshad Soni, Keyur Bhatt, Kvvn Raju, Murali K Voonna, Rakshit Shah, Chetna Shah, Dignesh Patel
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Abstract
Aims and background: Various 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 methods: A 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).
Results: There 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.
Conclusion: The 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 article: Goyal 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.
目的和背景：目前有多种肠外营养产品，每种产品都有特定的配方，旨在满足腹部手术后患者的不同营养需求。在此，我们对两种不同的肠外营养（PN）溶液 BFLUID 和 NUTRIFLEX PERI 的疗效和安全性进行了比较：一项前瞻性、多中心、随机、平行组、非劣效性 III 期临床试验比较了两种 PN 溶液，即 BFLUID（78 例）和 NUTRIFLEX PERI（72 例），对象是 150 名接受胃切除术或结肠切除术的患者。主要终点包括住院时间，次要终点包括ICU/HDU住院时间的评估和比较、感染和死亡事件的评估、血液中维生素B1水平的变化、营养参数的变化、血栓性静脉炎、注射部位疼痛以及不良事件（AEs）的记录：结果：两组在住院时间、重症监护室/重症加护病房住院时间、营养指标与基线相比的变化以及血液中维生素 B1 含量与基线相比的变化方面均无明显差异。两组研究在不良反应、注射部位疼痛和静脉炎发生率方面具有可比性。两组报告的不良事件在数量和严重程度上没有明显差异。此外，两组患者均未发现感染迹象：该试验成功证明了 BFLUID 不劣于 NUTRIFLEX PERI。此外，试验结果表明，富含高水平支链氨基酸（BCAAs）、必需氨基酸（EAAs）和硫胺素的 PN 对于接受胃切除术或结肠切除术的成年患者既安全又有效：Goyal 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：印度 III 期临床试验。Indian J Crit Care Med 2024;28(9):871-878.
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Indian Journal of Critical Care Medicine (ISSN 0972-5229) is specialty periodical published under the auspices of Indian Society of Critical Care Medicine. Journal encourages research, education and dissemination of knowledge in the fields of critical and emergency medicine.
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