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Study in ICU Patients Regarding Protein Intake and CT-derived Body Composition

A Retrospective Investigator Initiated Trial Evaluating Protein Intake and CT Assessments of Muscle Mass of Critically Ill Patients in Relation to Outcome Parameters: the PROMUS-study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02817646
Enrollment
800
Registered
2016-06-29
Start date
2012-02-29
Completion date
2018-07-31
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Atrophy

Keywords

Intensive Care Unit, Critical Illness, Body composition, Protein nutrition

Brief summary

The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.

Detailed description

Optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. However, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. Computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass. The investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. This is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. Therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass. Additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. Finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.

Interventions

OTHERComputed tomography scan made for clinical reasons

Patients were included if a computed tomography scan of the abdomen or thorax was made early during intensive care admission (1 day before up to 4 days after admission)

DIETARY_SUPPLEMENTNutrition as per hospital protocol

Patients received enteral and/or parenteral nutrition as per usual hospital protocol

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit * Length of intensive care stay of at least 4 days * Mechanical ventilation during intensive care stay

Exclusion criteria

* Computed tomography scan not eligible for analysis * Missing data

Design outcomes

Primary

MeasureTime frame
All-cause mortality6-months after intensive care admission

Secondary

MeasureTime frame
Percentage of patients discharged to homeAfter discharge from the hospital, on average after one month
Length of hospital stay (days)The total duration of admission to the hospital, an average of one month
Length of intensive care unit stayThe total duration of admission to the intensive care unit, an average of two weeks
Length of ventilationThe total duration of mechanical ventilation during intensive care unit stay, an average of 10 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026