PRotEin Provision in Critical IllneSs

NCT04633421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 935

Last updated 2024-01-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633421 on ClinicalTrials.gov