BeNeFIT18574: Einfluss einer proteinreichen im Vergleich zu einer normalen enteralen Ernährung auf die Genesung nach der Aufnahme auf die Intensivstation: eine randomisierte, dreifach blinde Studie an kritisch kranken, mechanisch beatmeten Patienten -

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
Title

The impact of high versus standard enteral protein provision on functional recovery following Intensive Care admission: a triple blind, randomized controlled, multicentre, parallel group trial in mechanically ventilated, critically ill patients

Participants (P)

Adult, mechanically ventilated patients admitted to the ICU with a clear indication for enteral nutrition (i.e. an expected stay on ventilator of at least 3 days).

Intervention (I)

Enteral nutrition with a high protein (8g protein/100 kcal) and normal energy content (i.e. isocaloric, isovolumetric)

Control (C)

Enteral nutrition containing standard protein (5g protein/100 kcal) and normal energy content (i.e. isocaloric, isovolumetric)

Outcome (O)

The primary objective of the PRECISE study is to assess whether increased enteral protein provision during critical illness improves Health Related Quality of Life after ICU admission.

Trial Design

The PRECISE trial is a pragmatic, international multi-centre, randomized controlled, triple-blind study comparing two isocaloric, isovolumetric enteral feeds with either a standard (5g protein/100 kcal) or high (8g protein/100 kcal) protein content in adult, mechanically ventilated patients admitted to an Intensive Care Unit.

Sample Size

824 patients

Trial duration

27 months

Budget

€1.85M (Bel: €0.91M)

Status

Open

 

Trial team

Sponsor

International study sponsor :  Maastricht Universitaire Medische Centrum

Belgian Coordinating Center: Ziekenhuis Oost-Limburg

Chief Investigator

Sponsor: Prof. Dr. Van De Poll

BCC: Prof. Dr. Dieter Mesotten

 

Sites

NL: 4 centres (MUMC+, Gelderse Vallei Ede, Zuyderland Heerlen, MST Enschede)

Bel: 5 centres (ZOL, CHU Liège, VUB, CHR de la Citadelle, Groeninge Kortrijk)
Dokumente
Protocol  
Report

Q3/2022

Publication

 

REFERENZEN

Clinicaltrials.gov: NCT04633421

Webpage:  https://www.preciseclinicaltrial.com

Finanzierungssystem
Published on: 
2020/06/04