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Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three‐Chamber Bags vs Compounded Monobags—A Prospective, Multicenter, Randomized, Single‐Blind Clinical Trial
Author(s) -
Yu Jianchun,
Wu Guohao,
Tang Yun,
Ye Yingjiang,
Zhang Zhongtao
Publication year - 2017
Publication title -
nutrition in clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.725
H-Index - 71
eISSN - 1941-2452
pISSN - 0884-5336
DOI - 10.1177/0884533617701883
Subject(s) - medicine , regimen , parenteral nutrition , adverse effect , randomized controlled trial , prospective cohort study , clinical trial , surgery
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 (Δ Prealb(StudyGroup) = 2.65 mg/dL, P < .001 vs Δ Prealb(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.