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Critical IllnessNCT04262531

Body Composition Study in Critically Ill Patients

An observational study of Critical Illness and Muscle Loss, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Critical Illness, Muscle Loss
How many people
90 participants
Where
1 siteMalaysia
Study dates
5 Jul 2019to 1 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult mechanically ventilated critically ill patients who are expected to stay at least 96 hours in the intensive care unit.

Who may be able to join

  • ≥ 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University of Malaya

    Kuala Lumpur, 50603

Other trials in Malaysia

About this study

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

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.

Read the 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.

Keywords
Critical Illness, muscle, mortality
Medical subject headings
Critical Illness, Muscular Atrophy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rectus Femoris Thickness

    Change in rectus femoris thickness

    Measured: 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)

  2. Rectus Femoris Cross-sectional area

    Change in rectus femoris cross-sectional area

    Measured: 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 (4)

  1. Ultrasound quadriceps echogenicity

    Change in quadriceps echogenicity

    Measured: 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)

  2. Ultrasound quadriceps pennation angle

    Change in quadriceps pennation angle

    Measured: 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)

  3. Ultrasound quadriceps fascicle length

    Change in quadriceps fascicle length

    Measured: 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)

  4. Bioelectrical Impedance Analysis (BIA) phase angle

    Change in whole body BIA phase angle

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start5 Jul 2019
  3. Primary completion1 Feb 2020
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262531
Sponsor's protocol ID
MREC ID NO: 2019615-7520
Status last verified
Nov 2020
First submitted
15 Jan 2020
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26838530

  • Lee ZY, Heyland DK. Determination of Nutrition Risk and Status in Critically Ill Patients: What Are Our Considerations? Nutr Clin Pract. 2019 Feb;34(1):96-111. doi: 10.1002/ncp.10214. Epub 2018 Nov 23.

    PubMed 30468264

  • White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Enteral Nutr. 2012 May;36(3):275-83. doi: 10.1177/0148607112440285.

    PubMed 22535923

  • Prado CM, Heymsfield SB. Lean tissue imaging: a new era for nutritional assessment and intervention. JPEN J Parenter Enteral Nutr. 2014 Nov;38(8):940-53. doi: 10.1177/0148607114550189. Epub 2014 Sep 19.

    PubMed 25239112

  • Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

    PubMed 24108501

  • Mourtzakis M, Parry S, Connolly B, Puthucheary Z. Skeletal Muscle Ultrasound in Critical Care: A Tool in Need of Translation. Ann Am Thorac Soc. 2017 Oct;14(10):1495-1503. doi: 10.1513/AnnalsATS.201612-967PS.

    PubMed 28820608

  • Thibault R, Makhlouf AM, Mulliez A, Cristina Gonzalez M, Kekstas G, Kozjek NR, Preiser JC, Rozalen IC, Dadet S, Krznaric Z, Kupczyk K, Tamion F, Cano N, Pichard C; Phase Angle Project Investigators. Fat-free mass at admission predicts 28-day mortality in intensive care unit patients: the international prospective observational study Phase Angle Project. Intensive Care Med. 2016 Sep;42(9):1445-53. doi: 10.1007/s00134-016-4468-3. Epub 2016 Aug 11.

    PubMed 27515162

  • 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.

    PubMed 32919818

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Muscle Loss, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262531, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.

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