Clinical trial NCT04262531: Body Composition Study in Critically Ill Patients
Official title: Body Composition and Clinical Outcomes in Critically Ill Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Muscle Loss
Keywords: Critical Illness
muscle
mortality
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult mechanically ventilated critically ill patients who are expected to stay at least 96 hours in the intensive care unit.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rectus Femoris Thickness
timeFrame: 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)
measure: Rectus Femoris Cross-sectional area
timeFrame: 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)
Secondary outcomes:
measure: Ultrasound quadriceps echogenicity
timeFrame: 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)
measure: Ultrasound quadriceps pennation angle
timeFrame: 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)
measure: Ultrasound quadriceps fascicle length
timeFrame: 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)
measure: Bioelectrical Impedance Analysis (BIA) phase angle
timeFrame: 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)
Other outcomes:
measure: Percentage of participant who died (Mortality)
timeFrame: Mortality at day 28 and day 60 (calculated from the first day of ICU admission)
measure: Survivors' long-term quality of life status
timeFrame: 6 months after ICU admission
measure: Katz Activities of Daily Living (ADL)
timeFrame: 6 months after ICU admission
measure: Lawton Instrumental Activities of Daily Living (IADL)
timeFrame: 6 months after ICU admission
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: University of Malaya
name: Ng Ching Choe Chloe
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.
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citation: Lee ZY, Ong SP, Ng CC, Yap CSL, Engkasan JP, Barakatun-Nisak MY, Heyland DK, Hasan MS. Association between ultrasound quadriceps muscle status with premorbid functional status and 60-day mortality in mechanically ventilated critically ill patient: A single-center prospective observational study. Clin Nutr. 2021 Mar;40(3):1338-1347. doi: 10.1016/j.clnu.2020.08.022. Epub 2020 Aug 28.