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

NCT02817646 | Completed

• 1 other identifier: ICUPROMUS
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscular Atrophy

Keywords

Intensive Care Unit; Critical Illness; Body composition; Protein nutrition

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (1)

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; Dietary Supplement: Nutrition as per hospital protocol

Interventions

Computed tomography scan made for clinical reasons OTHER

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)

Intensive care patients

Nutrition as per hospital protocol DIETARY_SUPPLEMENT

Patients received enteral and/or parenteral nutrition as per usual hospital protocol

Intensive care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit

You may qualify if:

• 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

You may not qualify if:

• Computed tomography scan not eligible for analysis
• Missing data

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Related Publications (3)

• 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.

  PMID: 25499096 BACKGROUND

• 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.

  PMID: 24410863 RESULT

• 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.

  PMID: 27903267 RESULT

MeSH Terms

Conditions

Muscular Atrophy; Critical Illness

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Peter J. Weijs, PhD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 29, 2016
• Study Start: February 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share