Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial

Nutr Clin Pract. 2017 Aug;32(4):545-551. doi: 10.1177/0884533617701883. Epub 2017 May 24.

Abstract

Background: Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time.

Materials and methods: This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded.

Results: In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (ΔPrealb(StudyGroup) = 2.65 mg/dL, P < .001 vs ΔPrealb(ControlGroup) = 0.27 mg/dL, P = .606) and CRP values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t(StudyGroup) = 4.90 ± 4.41 minutes vs t(ControlGroup) = 12.13 ± 5.62 minutes, P < .001). No differences were detected for LOS, 30-day mortality, safety laboratory parameters, and postoperative AEs (37 vs 38 in study and control groups).

Conclusion: The PN regimen provided by the 3-chamber bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

Keywords: 3-chamber bags; compounding; efficacy; multichamber bags; nutritional support; parenteral nutrition; parenteral nutrition solutions; patient; treatment outcome.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Body Mass Index
  • C-Reactive Protein / metabolism
  • Drug Compounding*
  • Female
  • Follow-Up Studies
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Parenteral Nutrition Solutions / chemistry*
  • Parenteral Nutrition Solutions / pharmacology*
  • Parenteral Nutrition*
  • Patient Compliance
  • Postoperative Period
  • Prealbumin / metabolism
  • Prospective Studies
  • Single-Blind Method
  • Young Adult

Substances

  • Parenteral Nutrition Solutions
  • Prealbumin
  • C-Reactive Protein