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

NCT ID: NCT07312708

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 620 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2026-02-01

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.

Detailed Description

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.

Conditions

Critical Illness

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

ABW fed

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

No interventions assigned to this group

FFM fed

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelderse Vallei Hospital

OTHER

Sponsor Role: lead

Responsible Party

ARH van Zanten, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gelderse Vallei Hospital

Ede, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

M. C. Paulus, MD

Role: CONTACT

Phone: 0318434868

Email: mpaulus@zgv.nl

Facility Contacts

M. C. Paulus, MD

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: V2

View Document

Other Identifiers

2403-017

Identifier Type: -

Identifier Source: org_study_id