The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients

Abstract

Background Critically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets. Methods The PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models. Discussion The PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes. Trial registration ClinicalTrials.gov Identifier: NCT04633421. Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.

Study protocol for TARGET protein: The effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: A cluster randomised, cross-sectional, double cross-over, clinical trial

“…The PRECISE study is an additional trial that aims to evaluate high enteral protein compared to standard enteral protein provision on functional recovery (health related quality of life) following ICU admission. 47 The estimated completion date for this trial is December 2023.…”

Editorial: The interaction between protein delivery and blood urea and ammonia during critical illness

“…PRECISe is a multicentre, parallel-group, blinded randomized clinical trial and will compare protein delivery at 1.3 or 2.0 g/kg/day (Clinical-Trials.gov NCT04633421) [16]. The investigators plan to enrol 935 patients and assess functional recovery at 1, 3 and 6 months.…”