Protein dosing by actual body weight versus fat-free mass for ICU patients
LEan Body Mass Development in CriTically Ill Patients, Obtained by bioelectRical impEdance Analysis: a Combined Retrospective and Prospective Observational Cohort Study
This project tests whether giving protein based on fat-free mass instead of actual body weight helps preserve muscle and improve recovery for adults in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 620 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gelderse Vallei Hospital Academic / other |
| Locations | 1 site (Ede) |
| Trial ID | NCT07312708 on ClinicalTrials.gov |
What this trial studies
This observational cohort compares two protein-prescribing approaches used at Gelderse Vallei Hospital: historically protein dosed by actual body weight (1.5 g/kg) versus more recent prescriptions based on fat-free mass measured by bioelectrical impedance analysis (BIA). BIA has been routine in the ICU since April 2020, allowing inclusion of patients with an initial BIA within 48 hours of admission and at least one follow-up BIA. No extra procedures are performed for patients already admitted; data are drawn from an anonymized clinical database with an opt-out information process. Outcomes focus on muscle preservation and recovery metrics during the ICU stay across the two dosing approaches.
Who should consider this trial
Good fit: Adults admitted to the ICU at Gelderse Vallei Hospital who have a BIA measurement within 48 hours of admission and at least one follow-up BIA during their stay are the ideal candidates.
Not a fit: Patients transferred from another ICU with a first BIA more than 48 hours after admission, those with a recent prior ICU admission within two weeks, or patients without BIA data are not included and would not directly benefit from this dataset.
Why it matters
Potential benefit: If successful, this work could lead to more accurate protein prescriptions that better preserve muscle mass and speed recovery for critically ill adults.
How similar studies have performed: Previous research shows that protein dose matters in critical illness, but using BIA-measured fat-free mass to guide protein prescriptions is relatively novel and has limited direct trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old * a BIA measurement available within 48 hours after ICU admission * at least one follow-up BIA measurement during ICU stay. Exclusion Criteria: * transfer from another ICU resulting in the first BIA measurement \>48 hours after admission to GVH * a previous ICU admission within 2 weeks before the current admission.
Where this trial is running
Ede
- Gelderse Vallei Hospital — Ede, Netherlands (Recruiting)
Study contacts
- Study coordinator: M. C. Paulus, MD
- Email: mpaulus@zgv.nl
- Phone: 0318434868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.