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The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients
Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function. The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.
ICU-acquired weakness (ICU-AW) is frequent among ICU survivors and negatively affects both short and long term outcomes. ICU-AW is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of ICU admission.Therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after ICU discharge are urgently needed. Retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. Current ICU guidelines recommend dietary protein delivery at 1.3 g/kg/day (ESPEN), or even up to 2.0 g/kg/day (ASPEN). However, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. Therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients. The focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. Previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. Therefore, it is nowadays increasingly recognized to move primary ICU trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UZ Brussel
Brussels, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
AZ Groeninge
Kortrijk, Belgium
CHR de la Citadelle
Liège, Belgium
CHU Liège
Liège, Belgium
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, Netherlands
Gelderse Vallei Ede
Ede, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Maastricht Universtair Medisch Centrum
Maastricht, Netherlands
Start Date
November 19, 2020
Primary Completion Date
October 3, 2023
Completion Date
October 3, 2023
Last Updated
January 22, 2024
935
ACTUAL participants
PRECISe protocol EN 8g protein/100kcal
DIETARY_SUPPLEMENT
PRECISe protocol EN 5g protein/100kcal
DIETARY_SUPPLEMENT
Lead Sponsor
Maastricht University Medical Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07478380