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

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ClinicalTrials.gov Identifier: NCT02817646
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wilhelmus G.P.M. Looijaard, MD, VU University Medical Center

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.

Condition or disease Intervention/treatment
Muscular Atrophy 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.

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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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 Start Date : February 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : July 2018

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




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 6-months after intensive care admission ]
  2. All-cause mortality [ Time Frame: 28-days after intensive care admission ]
  3. All-cause mortality [ Time Frame: 60-days after intensive care admission ]
  4. All-cause mortality [ Time Frame: 90-days after intensive care admission ]
  5. All-cause mortality [ Time Frame: From admission to the intensive care unit untill discharge from the intensive care unit, an average of two weeks ]
  6. All-cause mortality [ Time Frame: From admission to the intensive care unit untill discharge from the hospital, an average of one month ]

Secondary Outcome Measures :
  1. Percentage of patients discharged to home [ Time Frame: After discharge from the hospital, on average after one month ]
  2. Length of hospital stay (days) [ Time Frame: The total duration of admission to the hospital, an average of one month ]
  3. Length of intensive care unit stay [ Time Frame: The total duration of admission to the intensive care unit, an average of two weeks ]
  4. Length of ventilation [ Time Frame: The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the intensive care unit
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817646


Sponsors and Collaborators
VU University Medical Center
Investigators
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Study Director: Peter J. Weijs, PhD VU University Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Wilhelmus G.P.M. Looijaard, MD, PhD Candidate, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02817646    
Other Study ID Numbers: ICUPROMUS
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wilhelmus G.P.M. Looijaard, MD, VU University Medical Center:
Intensive Care Unit
Critical Illness
Body composition
Protein nutrition
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases