Body Composition Study in Critically Ill Patients

NCT ID: NCT04262531

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2020-06-01

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.

Conditions

Critical Illness; Muscle Loss

Keywords

Critical Illness; muscle; mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ng Ching Choe Chloe

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

University of Malaya

Kuala Lumpur, , Malaysia

Countries

Malaysia

References

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.

Reference Type: BACKGROUND

PMID: 26838530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30468264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22535923 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25239112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24108501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28820608 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27515162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32919818 (View on PubMed)

Other Identifiers

MREC ID NO: 2019615-7520

Identifier Type: -

Identifier Source: org_study_id