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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Muscular Atrophy

Intervention / Treatment
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* Other: Computed tomography scan made for clinical reasons
* Dietary Supplement: Nutrition as per hospital protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive care patients<br>Patients admitted to the intensive care unit for 4 days or more with a computed tomography scan made for clinical reasons early during intensive care stay and who receive enteral and/or parenteral nutrition as per hospital protocol | Other: Computed tomography scan made for clinical reasons<br>* 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)<br>Dietary Supplement: Nutrition as per hospital protocol<br>* Patients received enteral and/or parenteral nutrition as per usual hospital protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 6-months after intensive care admission | 
| All-cause mortality |  | 28-days after intensive care admission | 
| All-cause mortality |  | 60-days after intensive care admission | 
| All-cause mortality |  | 90-days after intensive care admission | 
| All-cause mortality |  | From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks | 
| All-cause mortality |  | From admission to the intensive care unit untill discharge from the hospital, an average of one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Length of ventilation |  | The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Critical Illness, Body composition, Protein nutrition