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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscular Atrophy
- Sponsor
- Amsterdam UMC, location VUmc
- Enrollment
- 800
- Primary Endpoint
- All-cause mortality
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Wilhelmus G.P.M. Looijaard, MD
PhD Candidate
Amsterdam UMC, location VUmc
Eligibility Criteria
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
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: From admission to the intensive care unit untill discharge from the hospital, an average of one month
Secondary Outcomes
- Length of ventilation(The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days)
- Percentage of patients discharged to home(After 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 stay(The total duration of admission to the intensive care unit, an average of two weeks)