BeNeFIT18574: The impact of high vs standard enteral protein provision on functional recovery following Intensive Care admission: a triple blind randomized controlled trial in mechanically ventilated, critically ill patients - PRECISE

Summary (French or Dutch)

Nutrition is an important part of treatment in the Intensive Care Unit (ICU) because patients consume and need a lot of energy during their admission. The goal of good nutrition is that patients stay as strong as possible and get through their intensive care admission as well as possible. The amount of protein in particular seems to be very important here; the breakdown of muscle protein is an important reason why patients become very weak during an Intensive Care (IC) admission. When participating, patients are randomised between two groups:
1. A group receives food with the standard amount of protein
2. Another group receives food with a higher amount of protein.
The food is used during the intensive care admission.
With this research we want to see whether giving more protein than usual to reduce this muscle breakdown can speed up recovery after intensive care admission.
Giving food via a feeding probe is standard care in intensive care and both amounts of protein are already applied in daily practice.
We just want to view which of the two power supplies is the best. The treatment is therefore no different from the usual care.
The follow-up after intensive care is different than usual. Normally, a doctor's check may take place once only once 3-6 months after an IC admission. Now that will be 3 times and recovery to be tested more extensively than usual.

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)
Documents
Protocol  
Report

Q3/2022

Publication

 

References

Clinicaltrials.gov: pending

Webpage: 

Funding scheme