The effect of an intervention of porcine protein versus maltodextrin supplement on CONvalescence of FUnCtional outcomes after IcU Stay (CONFUCIUS): Study protocol for a randomized controlled, single-center, double-blind trial

Abstract

Background: Patients discharged from the Intensive Care Unit (ICU) frequently suffer from ICU-acquired weakness because of immobilization and massive inflammation-induced muscle mass loss. Consequently, rehospitalization, reduced quality of life (QoL), increased disabilities, and higher post-ICU mortality is observed. Exercise rehabilitation and optimal nutrition, particularly protein intake, are pivotal to regaining muscle mass and function. Studies have shown that protein requirements in the post-ICU phase are often unmet. Furthermore, protein supplementation in other patient groups has shown beneficial effects. However, a study on protein supplementation during the post-ICU period is lacking. This study aims to investigate the effect of a six-week intervention of daily porcine protein supplementation versus an isocaloric control (maltodextrin) on functional outcomes in the post-ICU period in patients with moderately severe ICU-acquired weakness.

Methods: 72 post-ICU patients with moderately severe ICU-acquired weakness of Hospital Gelderse Vallei will be randomly assigned to either the intervention or the control group (36 per arm). The intervention group receives a porcine protein supplement twice a day. The control group receives a maltodextrin supplement twice a day. The intervention starts on the first day in the general ward and lasts 42 days (6 weeks). The primary outcome is the between-group difference in physical function at hospital discharge (t;=2), the end of the intervention (t;=3, day 42), and the 3-month follow-up (t;=4) expressed as a composite score consisting of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Secondary outcomes encompass physical function, QoL, Activity of daily living (ADL), and plasma amino acids concentrations. Lastly, ICU readmission after ICU discharge, hospital readmission after hospital discharge, and overall survival status will be considered. Linear mixed models will be used to test the treatment effect for the primary and secondary outcome measures.

Discussion: This trial will be the first to investigate porcine protein supplementation compared with carbohydrate supplementation in the post-ICU period aiming to improve functional outcomes of ICU survivors with moderately severe ICU-acquired weakness.

Trial registration: The study has been registered at ClinicalTrials.gov. Number: NCT05405764.

Keywords: ICU-acquired weakness; Intensive care; Nutrition; PICS; Physical function; Porcine protein; Randomized controlled trial; Recovery; Skeletal muscle.