Body Composition Study in Critically Ill Patients

NCT04262531 | Completed

• 1 other identifier: MREC ID NO: 2019615-7520
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Muscle Loss

Keywords

Critical Illness; muscle; mortality

Outcome Measures

Primary Outcomes (2)

• Rectus Femoris Thickness

  Change in rectus femoris thickness

  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)

• Rectus Femoris Cross-sectional area

  Change in rectus femoris cross-sectional area

  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)

• Ultrasound quadriceps echogenicity

  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)

• Ultrasound quadriceps pennation angle

  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)

• Ultrasound quadriceps fascicle length

  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)

• Bioelectrical Impedance Analysis (BIA) phase angle

  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 (4)

• Percentage of participant who died (Mortality)

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

• Survivors' long-term quality of life status

  6 months after ICU admission

• Katz Activities of Daily Living (ADL)

  6 months after ICU admission

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (8)

• 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.

  PMID: 26838530 BACKGROUND

• 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.

  PMID: 30468264 BACKGROUND

• 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.

  PMID: 22535923 BACKGROUND

• 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.

  PMID: 25239112 BACKGROUND

• 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.

  PMID: 24108501 BACKGROUND

• 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.

  PMID: 28820608 BACKGROUND

• 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.

  PMID: 27515162 BACKGROUND

• 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.

  PMID: 32919818 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Ng Ching Choe Chloe

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 10, 2020
• Study Start: July 5, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

MY (1)