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Completed

NCT Number: NCT04262531

Body Composition Study in Critically Ill Patients

This is a single-center prospective observational study that aimed to describe the trajectory of change in body composition among critically ill patients who were able to function independently prior to admission. Ultrasound measurement of the quadriceps muscle and bioelectrical impedance analysis will be conducted at baseline, day 7, day 14 and before ICU discharge. The relationship between the change of body composition and clinical outcomes, activities of daily living and quality of life at 6-month post ICU admission will be investigated. Further, the association between nutritional (energy and protein) intake and change in body composition will also be investigated.

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Key information

About this study

Malnutrition is associated with poor clinical outcomes. Nutritional status is closely linked with body lean mass, specifically the skeletal muscle. Several tool s had been suggested to determine nutrition risk and status for critically ill patients such as The Nutrition Risk in Critically Ill (NUTRIC) and subjective global assessment (SGA). However, they are surrogate (NUTRIC) or subjective (SGA) measures of nutritional status. Ideally, clinicians should measure muscle directly to determine the patient nutritional status. Several imaging techniques allow direct and accurate measurement of muscle mass, these include magnetic resonance imaging (MRI) and computed-tomography (CT). However, the measurement of MRI and CT involves the transfer of patients out of the intensive care unit or expose the patient to radiation (CT) and therefore it is not justifiable to conduct MRI or CT for the sole purpose of measuring body composition. Ultrasound and bioelectrical impedance analysis (BIA) are non-invasive and can be conducted at the bedside and therefore are promising techniques in assessing patients' nutritional status. Ultrasound measurement of quadriceps thickness and rectus femoris cross-sectional area can measure muscle directly and are widely used in the research setting. BIA phase angle is a direct measure of cell integrity and is an independent predictor of mortality in the ICU.

This study aimed to describe the trajectory of change in body composition and investigate the relationship of the changes with clinical outcomes and activities of daily living and quality of life at 6-month post ICU admission. Further, the association between nutritional (energy and protein) intake and change in body composition will also be investigated to determine if the ultrasound or BIA measurements of body composition can help to assess the response to nutritional intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years old
  • Mechanically ventilated* within 48 hours of ICU admission
  • Expected to stay in the ICU ≥96 hours
  • CT imaging is done within 72 hours prior and after ICU admission (only applicable for CT analysis)

Exclusion criteria

  • Pregnant
  • Expected death or discussion to withdraw life-sustaining treatments within this hospitalization
  • Patients in the hospital (either in the ward or ICU) ≥5 days in the past 2 weeks before enrolment
  • Not ambulating independently prior to illness that led to ICU admission (use of gait aid permitted). Also exclude if unable to walk 50 feet (15 meters) prior to hospitalization
  • Pre-existing (chronic or acute presentation) primary systemic neuromuscular disease (e.g. Guillain Barre)
  • Patient on pacemaker
  • Bilateral lower limb deep vein thrombosis
  • Presence of iliopsoas abscess or hematoma (only applicable for CT analysis)

Treatment and study plan

Primary outcomes

  1. Rectus Femoris Thickness

    Time frame: Change in rectus femoris thickness and cross-sectional area at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in rectus femoris thickness

  2. Rectus Femoris Cross-sectional area

    Time frame: Change in rectus femoris thickness and cross-sectional area at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in rectus femoris cross-sectional area

Secondary outcomes

  1. Ultrasound quadriceps echogenicity

    Time frame: Change in quadriceps echogenicity, pennation angle and fascicle length at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in quadriceps echogenicity

  2. Ultrasound quadriceps pennation angle

    Time frame: Change in quadriceps echogenicity, pennation angle and fascicle length at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in quadriceps pennation angle

  3. Ultrasound quadriceps fascicle length

    Time frame: Change in quadriceps echogenicity, pennation angle and fascicle length at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in quadriceps fascicle length

  4. Bioelectrical Impedance Analysis (BIA) phase angle

    Time frame: Change in whole body BIA phase angle at day 7, 14 and within 72 hours of ICU discharge compared with baseline (Day 1 of ICU admission)

    Change in whole body BIA phase angle

Other outcomes

  1. Percentage of participant who died (Mortality)

    Time frame: Mortality at day 28 and day 60 (calculated from the first day of ICU admission)

    Mortality at day 28, day 60, in the ICU and in the Hospital

  2. Survivors' long-term quality of life status

    Time frame: 6 months after ICU admission

    Survivors' quality of life status at 6 months of ICU admission by administering Euro Quality of Life 5-level questionnaire (EQ-5D-5L) via telephone interview. The are 5 questions and each question will have 5 categories (Level 1 is the best and level 5 is worst).

  3. Katz Activities of Daily Living (ADL)

    Time frame: 6 months after ICU admission

    Survivors' ADL status at 6 months of ICU admission by administering Katz ADL questionnaire via telephone interview. Katz ADL has 5 questions with score ranging from 0 to 6, higher score is better.

  4. Lawton Instrumental Activities of Daily Living (IADL)

    Time frame: 6 months after ICU admission

    Survivors' IADL status at 6 months of ICU admission by administering Lawton IADL questionnaire via telephone interview. Lawton IADL has 8 questions with score ranging from 0 to 8, the higher score is better.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Body Composition and Clinical Outcomes in Critically Ill Patients: A Prospective Observational Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Nov 6, 2020

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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