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Body Composition Study in Critically Ill Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04262531
Enrollment
90
Registered
2020-02-10
Start date
2019-07-05
Completion date
2020-06-01
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Muscle Loss

Keywords

Critical Illness, muscle, mortality

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.

Interventions

None listed

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Rectus Femoris ThicknessChange 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
Rectus Femoris Cross-sectional areaChange 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

MeasureTime frameDescription
Ultrasound quadriceps pennation angleChange 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
Ultrasound quadriceps echogenicityChange 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
Ultrasound quadriceps fascicle lengthChange 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
Bioelectrical Impedance Analysis (BIA) phase angleChange 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

MeasureTime frameDescription
Katz Activities of Daily Living (ADL)6 months after ICU admissionSurvivors' 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.
Lawton Instrumental Activities of Daily Living (IADL)6 months after ICU admissionSurvivors' 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.
Survivors' long-term quality of life status6 months after ICU admissionSurvivors' 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).
Percentage of participant who died (Mortality)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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026