Protein Dosing Strategies in Critically Ill Patients: Comparing Actual Body Weight and Fat-Free Mass Approaches in an Observational Cohort Study

NCT07312708 | Recruiting

• 1 other identifier: 2403-017
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

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

Critical Illness

Keywords

proteins; critical illness; lean body mass; fat free mass; BIA

Outcome Measures

Primary Outcomes (1)

• Mortality

  Short (ICU and 30-day mortality) and long-term mortality (90 days)

  Mortality, defined as death from any cause, from ICU admission until 90 days post-admission

Secondary Outcomes (6)

• ICU and hospital length of stay

  From ICU admission until the date of ICU discharge or the documented date of death from any cause, whichever comes first, assessed up to 52 weeks after ICU admission

• Duration of invasive mechanical ventilation (IMV)

  Number of days on invasive mechanical ventilation (IMV), defined as the total number of days with IMV from initiation until ICU discharge, assessed up to 52 weeks after ICU admission

• Urea-creatinine ratio during ICU stay

  All UCR measurements taken during the ICU stay, from ICU admission to ICU discharge, with each measurement recorded daily and specified by the day relative to ICU admission, up to a maximum of 52 weeks

• Changes in BIA parameters over time (in kg)

  All BIA measurements during the ICU stay, including dry fat-free mass, skeletal muscle mass and fat mass, recorded daily from ICU admission to ICU discharge, up to 52 weeks.

• Changes in BIA water parameters over time (in L)

  All BIA measurements during the ICU stay, such as intracellular water, extracellular water, and total body water, recorded daily from ICU admission to ICU discharge, up to 52 weeks

Other Outcomes (3)

• Protein intake during ICU stay

  Daily intake for the first 14 days since ICU admission, or all days on the ICU if this is less than 14 days

• Energy intake during ICU stay

  Daily energy intake for the first 14 days since ICU admission, per day, of all days of ICU stay if ICU stay is shorter than 14 days

• Changes in Resting Energy Expenditure (REE) measured with indirect calorimetry

  All REE measurements during the ICU stay, recorded daily from ICU admission to ICU discharge, up to 52 weeks

Study Arms (2)

ABW fed

This group received proteins based on 1.5 grams per kilogram actual body weight

FFM fed

This group received proteins based on 1.85 grams per kilogram fat free mass (BIA determined)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill adult patients

You may qualify if:

• ≥18 years old
• a BIA measurement available within 48 hours after ICU admission
• at least one follow-up BIA measurement during ICU stay.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gelderse Vallei Hospital: lead

Study Sites (1)

Gelderse Vallei Hospital

Ede, 6716RP, Netherlands

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

M. C. Paulus, MD

CONTACT

0318434868; mpaulus@zgv.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 31, 2025
• Study Start: April 1, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)