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

Muscular Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817646
• Other study ID #: ICUPROMUS
• Status: Completed
• Start date: February 2012
• Est. completion date: July 2018

Study information

• Verified date: October 2018
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

References & Publications (3)

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. — View 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. — View 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/cc1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		6-months after intensive care admission
Primary	All-cause mortality		28-days after intensive care admission
Primary	All-cause mortality		60-days after intensive care admission
Primary	All-cause mortality		90-days after intensive care admission
Primary	All-cause mortality		From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks
Primary	All-cause mortality		From admission to the intensive care unit untill discharge from the hospital, an average of one month
Secondary	Percentage of patients discharged to home		After discharge from the hospital, on average after one month
Secondary	Length of hospital stay (days)		The total duration of admission to the hospital, an average of one month
Secondary	Length of intensive care unit stay		The total duration of admission to the intensive care unit, an average of two weeks
Secondary	Length of ventilation		The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days