Continuous peptide-based versus sequential standard polymeric enteral nutrition formula in critically ill patients with acute gastrointestinal injury: study protocol for a single-center, parallel-group randomized controlled trial.

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.