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Completed

NCT Number: NCT02817646

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Nutrition as per hospital protocol

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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