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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital length of stay | Duration of ICU and hospital length of stay in days | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Protein intake during ICU stay | Daily and cumulative (during the first 14 days) 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 |
Inclusion Criteria:
Exclusion Criteria:
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Critically ill adult patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M. C. Paulus, MD | Contact | 0318434868 | mpaulus@zgv.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelderse Vallei Hospital | Recruiting | Ede | 6716RP | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42332775 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: V2 | Oct 20, 2025 | Dec 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Duration of invasive mechanical ventilation in days |
| 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 | 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) | 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 | 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 | All BIA measurements during the ICU stay, such as phase angle, recorded daily from ICU admission to ICU discharge, up to 52 weeks |
Daily and cumulative (during the first 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 | Changes in Resting Energy Expenditure (REE) | All REE measurements during the ICU stay, recorded daily from ICU admission to ICU discharge, up to 52 weeks |