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ID
Source
Brief title
Health condition
Conditions required ventilator support in the Intensive Care Unit
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
To associate course of REE with physical performance, using the MRC sum-score at ICU-discharge, hospital discharge and at 1-month follow-up.
Background summary
In this study, all patients consented into either arm of the PRECISe trial in one of the centres participating in the ProtEE substudy, will be screened for the additional ProtEE in- and exclusion criteria. Patients that meet all the inclusion criteria and none of the exclusion criteria will be included in this observational study in consecutive order. The indirect calorimeter will be used to measure REE parameters during ICU stay, within 24 hours of admission and once every third day (+/- 1 day) after that. The admission weight will be entered in all measurements to minimize the effect of fluid overload. Participating centres with access to a canopy-hood to measure REE in spontaneously breathing patients will continue measurements every 3rd day (+/- 1 day), after extubation and once a week in the ward after ICU-discharge, until hospital discharge, if feasible. All measurements will be performed in a steady-state situation (an RQ within physiologic range of 0.67 – 1.3 and a period of gas exchange defined by a 5-min interval during which VO2 and VCO2 vary by < 10%.). The output from the indirect calorimetry meter will not be used to adjust enteral nutrition dosage or composition as to not interfere with the PRECISe trial.
Study objective
The course of resting energy expenditure (REE), measured by indirect calorimetry changes based on standard versus high enteral protein feeding in the ICU.
Study design
Measurements will be done with the Q-NRG® Metabolic Monitor. From the start of the study until hospital discharge the measurements with the Metabolic Monitor will be assessed every third day (+/- 1 day), and, if feasible, once per week (+/- 1 day) after the 2nd measurement in general wards, or on the day of hospital discharge, whichever comes first.
The measurements for the MRC sum-score as mentioned in the secondary outcome will not be measured in this study, this will be done in the PRECISe core trial.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9510 |
| Other | BCWO Hospital Gelderse Vallei : BCWO 2101-014 |