Clinical trial NCT02817646: Study in ICU Patients Regarding Protein Intake and CT-derived Body Composition
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Atrophy
Keywords: Intensive Care Unit
Critical Illness
Body composition
Protein nutrition
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit

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.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: 6-months after intensive care admission
measure: All-cause mortality
timeFrame: 28-days after intensive care admission
measure: All-cause mortality
timeFrame: 60-days after intensive care admission
measure: All-cause mortality
timeFrame: 90-days after intensive care admission
measure: All-cause mortality
timeFrame: From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks
measure: All-cause mortality
timeFrame: From admission to the intensive care unit untill discharge from the hospital, an average of one month
Secondary outcomes:
measure: Percentage of patients discharged to home
timeFrame: After discharge from the hospital, on average after one month
measure: Length of hospital stay (days)
timeFrame: The total duration of admission to the hospital, an average of one month
measure: Length of intensive care unit stay
timeFrame: The total duration of admission to the intensive care unit, an average of two weeks
measure: Length of ventilation
timeFrame: The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Peter J. Weijs, PhD
role: STUDY_DIRECTOR
References:
citation: Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
citation: Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.
citation: Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Twisk JW, Oudemans-van Straaten HM, Weijs PJ. Skeletal muscle quality as assessed by CT-derived skeletal muscle density is associated with 6-month mortality in mechanically ventilated critically ill patients. Crit Care. 2016 Dec 1;20(1):386. doi: 10.1186/s13054-016-1563-3.