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NCT Number: NCT07312708

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gelderse Vallei Hospital

Ede, 6716RP, Netherlands

Location status: Recruiting

Location contact

M. C. Paulus, MD

CONTACT

[email protected]

+31318434868

About this study

Patients were enrolled through an opt-out procedure using an information leaflet included in the admission folder. The acquisition of informed consent from patients admitted between April 2020 and July 2023 was deemed neither necessary nor feasible, as the study relies on an anonymized database and no additional measurements are performed. Therefore, the internal committee for research evaluation approved the waiver of informed consent for these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

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

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

Secondary outcomes

  1. ICU and hospital length of stay

    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

    Duration of ICU and hospital length of stay in days

  2. Duration of invasive mechanical ventilation (IMV)

    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

    Duration of invasive mechanical ventilation in days

  3. Urea-creatinine ratio 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

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

  4. Changes in BIA parameters over time (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.

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

  5. Changes in BIA water parameters over time (in L)

    Time frame: 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

    Changes in BIA water (bioelectric impedance analysis) parameters in liters

  6. Changes in BIA phase angle

    Time frame: All BIA measurements during the ICU stay, such as phase angle, recorded daily from ICU admission to ICU discharge, up to 52 weeks

    Changes in BIA phase angle

Other outcomes

  1. 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

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

  2. 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

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

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

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

    Changes in Resting Energy Expenditure (REE)

Study contacts

Contact information is provided by the study sponsor or research team.

M. C. Paulus, MD

CONTACT

[email protected]

0318434868

Sponsors and collaborators

Lead sponsor

Gelderse Vallei Hospital

Other

Registry information

Official study title

LEan Body Mass Development in CriTically Ill Patients, Obtained by bioelectRical impEdance Analysis: a Combined Retrospective and Prospective Observational Cohort Study

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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