Randomized Clinical Trial
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Jun 27, 2024; 16(6): 1765-1774
Published online Jun 27, 2024. doi: 10.4240/wjgs.v16.i6.1765
Effect of high-protein peptide-based formula compared with isocaloric isonitrogenous polymeric formula in critically ill surgical patient
Preeda Sumritpradit, Prapimporn Chattranukulchai Shantavasinkul, Winai Ungpinitpong, Pinit Noorit, Chotip Gajaseni
Preeda Sumritpradit, Division of Trauma Surgery and Surgical Critical Care, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand
Prapimporn Chattranukulchai Shantavasinkul, Division of Nutrition and Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand
Prapimporn Chattranukulchai Shantavasinkul, Graduate Program in Nutrition, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand
Winai Ungpinitpong, Department of Surgery, Surin Hospital, Surin 32000, Thailand
Pinit Noorit, Department of Surgery, Chonburi Hospital, Chonburi 20000, Thailand
Chotip Gajaseni, Department of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand
Author contributions: Sumritpradit P conceived the original idea, designed the study, enrolled subjects, patient care, performed the interpretation of data, wrote manuscript, and revised the manuscript and corresponding to submit for publication; Shantavasinkul PC performed biochemistry analysis, took responsibility for integrity of data, wrote manuscript and revised the manuscript; Ungpinitpong W enrolled subjects, patient care, performed the statistical analysis data, took responsibility for accuracy of data, reviewed the manuscript and provided critical comments; Noorit P enrolled subjects, patient care, performed the interpretation of data, took responsibility for integrity of data, reviewed the manuscript and provided critical comments; Gajaseni C collected the data, coordinate with participants and site staff team for intervention. All authors read and approved the final manuscript.
Institutional review board statement: The study was approved by the Institutional Review Board from all institutes.
Clinical trial registration statement: The study was registered at the Thai Clinical Trials Registry (TCTR20220507003) before the first patient’s enrollment.
Informed consent statement: All patients voluntarily signed and dated the written informed consent.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Preeda Sumritpradit, MD, Associate Professor, Division of Trauma Surgery and Surgical Critical Care, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, No. 270 Rama VI Road, Thung Phaya Thai, Ratchathewi, Bangkok 10400, Thailand. psumritpradit@gmail.com
Received: January 26, 2024
Revised: April 3, 2024
Accepted: April 22, 2024
Published online: June 27, 2024
Processing time: 155 Days and 20.2 Hours
Abstract
BACKGROUND

Malnutrition is common in critically ill patients, and it is associated with an increased risk of complications. Early enteral nutrition with adequate caloric and protein intake is critical nevertheless it is difficult to achieve. Peptide-based formulas have been shown to be beneficial in patients with feeding intolerance. However, there are limited studies showing the efficacy and safety of high-protein peptide-based formula in critically ill surgical patients.

AIM

To determine the effects of a high-protein peptide formulation on gastrointestinal tolerance, nutritional status, biochemical changes, and adverse events in patients in the surgery intensive care unit (SICU) compared to an isocaloric isonitrogenous standard polymeric formulation.

METHODS

This study was a multi-center double-blind, randomized controlled trial. We enrolled adult patients in the surgical intensive care unit, age ≥ 15 years and expected to receive enteral feeding for at least 5-14 d post-operation. They were randomly assigned to receive either the high-protein peptide-based formula or the isocaloric isonitrogenous standard formula for 14 d. Gastric residual volume (GRV), nutritional status, body composition and biochemical parameters were assessed at baseline and on days 3, 5, 7, 9, 11, and 14.

RESULTS

A total of 19 patients were enrolled, 9 patients in the peptide-based formula group and 10 patients in the standard formula group. During the study period, there were no differences of the average GRV, body weight, body composition, nutritional status and biochemical parameters in the patients receiving peptide-based formula, compared to the standard regimen. However, participants in the standard formula lost their body weight, body mass index (BMI) and skeletal muscle mass significantly. While body weight, BMI and muscle mass were maintained in the peptide-based formula, from baseline to day 14. Moreover, the participants in the peptide-based formula tended to reach their caloric target faster than the standard formula.

CONCLUSION

The study emphasizes the importance of early nutritional support in the SICU and showed the efficacy and safety of a high-protein, peptide-based formula in meeting caloric and protein intake targets while maintaining body weight and muscle mass.

Keywords: Peptide-based formula; Surgical intensive care; Hydrolyzed protein; Surgery; Nutritional support

Core Tip: This study is to focus on early nutrition support by novel high protein, peptide-based formula in various surgical intensive care patients. The formula could help maintaining body weight and muscle mass of patients and help them to meet calories and protein requirement. In addition, this nutrition support improved serum albumin, prealbumin and retinol binding protein which lead to decrease risk of malnutrition. Besides nutritional status outcomes evaluation, we investigate wound healing improvement by plasma fibronectin which is protein for cell adhesion, wound healing and blood clotting in this study. This finding would be helpful for recovery surgical patients after operation.