Overview

This trial is active, not recruiting.

Condition muscular atrophy
Treatments computed tomography scan made for clinical reasons, nutrition as per hospital protocol
Sponsor VU University Medical Center
Start date February 2012
End date October 2016
Trial size 800 participants
Trial identifier NCT02817646, ICUPROMUS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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
computed 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)
nutrition as per hospital protocol
Patients received enteral and/or parenteral nutrition as per usual hospital protocol

Primary Outcomes

Measure
All-cause mortality
time frame: 6-months after intensive care admission

Secondary Outcomes

Measure
Percentage of patients discharged to home
time frame: After discharge from the hospital, on average after one month
Length of hospital stay (days)
time frame: The total duration of admission to the hospital, an average of one month
Length of intensive care unit stay
time frame: The total duration of admission to the intensive care unit, an average of two weeks
Length of ventilation
time frame: The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by VU University Medical Center.