Critical IllnessNCT07312708
Protein Dosing Strategies in Critically Ill Patients: Comparing Actual Body Weight and Fat-Free Mass Approaches in an Observational Cohort Study
An observational study of Critical Illness, run by Gelderse Vallei Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 620 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2020to 27 Jan 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients
Who may be able to join
- ≥18 years old
- a BIA measurement available within 48 hours after ICU admission
- at least one follow-up BIA measurement during ICU stay.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: LEan Body Mass Development in CriTically Ill Patients, Obtained by bioelectRical impEdance Analysis: a Combined Retrospective and Prospective 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.
Read more
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.
Read the 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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Short (ICU and 30-day mortality) and long-term mortality (90 days)
Measured: Mortality, defined as death from any cause, from ICU admission until 90 days post-admission
Secondary outcomes (6)
ICU and hospital length of stay
Duration of ICU and hospital length of stay in days
Measured: 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)
Duration of invasive mechanical ventilation in days
Measured: 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
Differences in urea-to-creatinine-ratio between both groups during ICU stay
Measured: 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)
Changes in BIA (bioelectric impedance analysis) parameters, including fat free mass, sketetal mass and fat mass (all in kg)
Measured: 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)
Changes in BIA water (bioelectric impedance analysis) parameters in liters
Measured: 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 phase angle
Changes in BIA phase angle
Measured: All BIA measurements during the ICU stay, such as phase angle, recorded daily from ICU admission to ICU discharge, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Apr 2020
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 620 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Gelderse Vallei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARH van Zanten, MD PhD, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312708
- Sponsor's protocol ID
- 2403-017
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paulus MC, Hajeer F, van Zanten ARH. Body composition-guided protein dosing in critically ill patients: a before-and-after study (PROGRESS-ICU). Crit Care. 2026 Jun 22. doi: 10.1186/s13054-026-06107-5. Online ahead of print.
PubMed 42332775
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEan Body Mass Development in CriTically Ill Patients, Obtained by bioelectRical impEdance Analysis: a Combined Retrospective and Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07312708
- Acronym / sponsor ID
- 2403-017
- Conditions
- Critical Illness
- Keywords
- proteins, critical illness, lean body mass, fat free mass, BIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Gelderse Vallei HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients
Key inclusion criteria (3 listed)
- ≥18 years old
- a BIA measurement available within 48 hours after ICU admission
- at least one follow-up BIA measurement during ICU stay.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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 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
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
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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42332775Paulus MC, Hajeer F, van Zanten ARH. Body composition-guided protein dosing in critically ill patients: a before-and-after study (PROGRESS-ICU). Crit Care. 2026 Jun 22. doi: 10.1186/s13054-026-06107-5. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Gelderse Vallei Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Mortality, defined as death from any cause, from ICU admission until 90 days post-admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.