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

NCT ID: NCT02817646

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Muscular Atrophy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Computed tomography scan made for clinical reasons

Intervention Type 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)

Nutrition as per hospital protocol

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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)

Intervention Type OTHER

Nutrition as per hospital protocol

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Wilhelmus G.P.M. Looijaard, MD

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter J. Weijs, PhD

Role: STUDY_DIRECTOR

Amsterdam UMC, location VUmc

References

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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.

Reference Type BACKGROUND
PMID: 25499096 (View on PubMed)

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.

Reference Type RESULT
PMID: 24410863 (View on PubMed)

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.

Reference Type RESULT
PMID: 27903267 (View on PubMed)

Other Identifiers

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ICUPROMUS

Identifier Type: -

Identifier Source: org_study_id

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