Actively Recruiting
Protein Dosing Strategies in Critically Ill Patients: Comparing Actual Body Weight and Fat-Free Mass Approaches in an Observational Cohort Study
Led by Gelderse Vallei Hospital · Updated on 2025-12-31
620
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates how different methods of calculating protein intake affect recovery and muscle preservation in critically ill patients in the Intensive Care Unit (ICU). Protein is essential for maintaining muscle strength, supporting healing, and improving recovery during critical illness. At Hospital Gelderse Vallei, patients admitted to the ICU received protein based on actual body weight until 2023; more recently, protein prescriptions have been based on fat-free mass. Bioelectrical impedance analysis (BIA) has been part of standard clinical practice in the ICU since April 2020, meaning that all patients admitted since then have been screened for inclusion in the study. This design allows for comparison between two groups: one group receiving protein based on actual body weight according to current clinical guidelines (1.5 g/kg body weight), and another group whose protein intake is calculated based on lean body mass (LBM) measured by BIA. BIA measurements are repeated during the ICU stay to monitor changes in body composition. A total of 310 patients admitted to the ICU between the start of BIA implementation in April 2020 and the transition to fat-free mass-based dosing in 2023 were identified. To allow for balanced comparison, an equal number of 310 patients from the subsequent period, in which protein dosing was based on fat-free mass, were included in the study. The study compares these two groups to determine whether calculating protein requirements based on lean body mass leads to better clinical outcomes-such as improved recovery (lower mortality and shorter hospital stay), preservation of muscle mass, and lower UCR-than the traditional method based on actual body weight. The data analysis plan was established prior to completion of patient inclusion and database lock.
CONDITIONS
Official Title
Protein Dosing Strategies in Critically Ill Patients: Comparing Actual Body Weight and Fat-Free Mass Approaches in an Observational Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- A bioelectrical impedance analysis (BIA) measurement available within 48 hours after ICU admission
- At least one follow-up BIA measurement during ICU stay
You will not qualify if you...
- Transfer from another ICU resulting in the first BIA measurement more than 48 hours after admission to Gelderse Vallei Hospital
- A previous ICU admission within 2 weeks before the current admission
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gelderse Vallei Hospital
Ede, Netherlands, 6716RP
Actively Recruiting
Research Team
M
M. C. Paulus, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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