ProtEE study

Recruiting

• Conditions: Conditions required ventilator support in the Intensive Care Unit

• Registration Number: NL-OMON20841
• Lead Sponsor: Maastricht UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the PRECISe study:

1.Adult = 18 years-old admitted to the ICU
2.Unplanned ICU admission
3.Invasive mechanical ventilation initiated <24 hours of ICU admission
4.Expected ICU stay on ventilator support of = 3 days

Exclusion Criteria

Any patient admitted to the Intensive Care Unit meeting one or more of the following criteria is not eligible for the PRECISe study:

1.Contraindication for enteral nutrition
2.Moribund or expected withholding of treatment
3.Kidney failure with no dialysis”-code on admission
4.Hepatic encephalopathy (West Haven 3 – 4)
5.Body-mass index <18 kg/m²

Additional exclusion criteria ProtEE study:
1.Fraction of inspired oxygen (FiO2) expected to remain > 0.7 for 24 hours after admission.
2.Positive end-expiratory pressure (PEEP) expected to remain > 12 cm H2O for 24 hours after admission.
3.Patient is on ECMO the first 24h after admission

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the course of resting energy expenditure (REE), measured by indirect calorimetry, during ICU stay (and after that until hospital discharge, when feasible), between patients fed with high versus standard enteral protein within the PRECISe trial.

Secondary Outcome Measures

Name	Time	Method
To associate course of REE with physical performance, using the MRC sum-score at ICU-discharge, hospital discharge and at 1-month follow-up.