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

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.

Study Overview

• Status: Completed
• Conditions: Muscular Atrophy
• Intervention / Treatment: Other: Computed tomography scan made for clinical reasons; Dietary supplement: Nutrition as per hospital protocol

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.

• Study Type: Observational
• Enrollment (Actual): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intensive care patients; 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; 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 supplement: Nutrition as per hospital protocol; Patients received enteral and/or parenteral nutrition as per usual hospital protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Study Director: Peter J. Weijs, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Body composition; Critical Illness; Protein nutrition
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: ICUPROMUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO