PRotEin Provision in Critical IllneSs
NCT04633421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 935
Last updated 2024-01-22
Summary
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.
Conditions
- Critical Illness
- Intensive Care Unit Acquired Weakness
Interventions
- DIETARY_SUPPLEMENT
-
PRECISe protocol EN 8g protein/100kcal
Enteral feed containing 8g protein/100kcal
- DIETARY_SUPPLEMENT
-
PRECISe protocol EN 5g protein/100kcal
Enteral feed containing 5g protein/100kcal
Sponsors & Collaborators
-
Ziekenhuis Oost-Limburg
collaborator OTHER -
Zuyderland Medisch Centrum
collaborator OTHER -
Gelderse Vallei Hospital
collaborator OTHER -
Medisch Spectrum Twente
collaborator OTHER -
Centre Hospitalier Universitaire de Liege
collaborator OTHER -
Centre Hospitalier Régional de la Citadelle
collaborator OTHER -
Universitair Ziekenhuis Brussel
collaborator OTHER -
General Hospital Groeninge
collaborator OTHER -
Catharina Ziekenhuis Eindhoven
collaborator OTHER -
Maastricht University Medical Center
lead OTHER
Principal Investigators
-
Marcel CG van de Poll, MD, PhD · Maastricht UMC+
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-19
- Primary Completion
- 2023-10-03
- Completion
- 2023-10-03
Countries
- Belgium
- Netherlands
Study Locations
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