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Published on: September 20, 2019
Continuous peptide-based versus sequential standard polymeric enteral nutrition formula in critically ill patients
Yanhua Li1, Youquan Wang1, Ying Chen1
1Department of Critical Care Medicine, The First Hospital of Jilin University, Changchun, China.
Insights
For critically ill patients with acute gastrointestinal injury (AGI), this study compares continuing peptide-based enteral formula (PBF) versus switching to standard polymeric formula (SPF) after gastrointestinal function improves. Findings will guide optimal nutritional support strategies.
Area of Science:
- Critical Care Medicine
- Clinical Nutrition
- Gastroenterology
Background:
- Peptide-based enteral formula (PBF) may benefit critically ill patients with acute gastrointestinal injury (AGI) initially.
- Optimal enteral formula choice after AGI improvement remains unclear.
Purpose of the Study:
- To compare the efficacy and safety of continuing PBF versus switching to standard polymeric formula (SPF) in critically ill patients with AGI.
- To evaluate nutritional support strategies from day 4 onward in patients with improved gastrointestinal function.
Main Methods:
- A single-center, randomized controlled trial with 1:1 allocation and intention-to-treat analysis.
- 496 adult critically ill patients with AGI grade I-II will be included.
- Interventions involve continuous PBF or a switch to SPF on ICU day 4 based on AGI grade.
Main Results:
- Primary outcome: mean daily energy intake on day 7 (kcal/kg/day).
- Secondary outcomes and process measures will be evaluated per protocol.
- Intention-to-treat analysis enhances result robustness.
Conclusions:
- The study will provide evidence on the optimal enteral formula strategy for critically ill patients with recovering gastrointestinal function.
- Findings aim to optimize nutritional management and patient outcomes in critical care settings.
Background:
In critically ill patients with acute gastrointestinal injury (AGI), early administration of a peptide-based enteral formula (PBF) may be beneficial during the acute phase. Nevertheless, after gastrointestinal function improves, it remains unclear whether continuing a PBF or switching to a standard polymeric formula (SPF) is preferable.
Objectives:
To compare the efficacy and safety of continuing a PBF versus switching to an SPF from day 4 onward in critically ill patients with AGI whose gastrointestinal function has recovered or improved to AGI grade I by day 4.
Design:
Single-center, parallel-group, randomized, controlled, trial with 1:1 allocation, intention-to-treat analysis.
Setting:
Three clinical units of the Department of Critical Care Medicine at the First Hospital of Jilin University (Changchun, China).
Participants:
We will ultimately include 496 adult critically ill patients with AGI grade I-II who meet the eligibility criteria in the final analysis.
Interventions:
Continuous Peptide-Based Enteral Formula Group (PBF group): patients will receive continuous infusion of a PBF, initiated within 7 days of ICU admission. Sequential Standard Polymeric Enteral Formula Group (SPF group): patients will receive a PBF during the first 3 days in the ICU and will be transitioned to an SPF if the AGI grade is 0-I on ICU day 4.
Primary Outcome Measure:
The primary outcome is the mean daily energy intake on day 7 (kcal/kg/day). An intention-to-treat analysis will be used to assess this outcome to enhance the robustness of the results. Secondary outcomes and relevant process measures will be evaluated in accordance with the study protocol.
Clinical Trial Registration:
https://www.chictr.org.cn/showproj.html?pid=139513, Identifier ChiCTR2200056858.
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