Zusammenfassung (Niederländisch oder Französisch oder Englisch)
| 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) |
| Sponsor | International study sponsor : Maastricht Universitair Medisch 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) |
Clinicaltrials.gov: NCT04633421
Webpage: https://www.preciseclinicaltrial.com