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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGelderse Vallei Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

a BIA measurement available within 48 hours after ICU admission

at least one follow-up BIA measurement during ICU stay.

Disqualifiers

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.

Trial population

Critically ill adult patients

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

620 Participants
are grouped into 2 trial groups
Group A: ABW fed
Group B: FFM fed

Trial outcomes

Primary outcomes

1

Mortality

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

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

Secondary outcomes

1

ICU and hospital length of stay

Duration of ICU and hospital length of stay in days

Time frame
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
2

Duration of invasive mechanical ventilation (IMV)

Duration of invasive mechanical ventilation in days

Time frame
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
3

Urea-creatinine ratio during ICU stay

Differences in urea-to-creatinine-ratio between both groups during ICU stay

Time frame
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
4

Changes in BIA parameters over time (in kg)

Changes in BIA (bioelectric impedance analysis) parameters, including fat free mass, sketetal mass and fat mass (all in kg)

Time frame
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.

Other outcomes

1

Protein intake during ICU stay

Daily and cumulative (during the first 14 days) protein intake during ICU stay

Time frame
Daily intake for the first 14 days since ICU admission, or all days on the ICU if this is less than 14 days
2

Energy intake during ICU stay

Daily and cumulative (during the first 14 days) energy intake during ICU stay

Time frame
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
3

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

Changes in Resting Energy Expenditure (REE)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.