Body Composition Study in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262531
• Other study ID #: MREC ID NO: 2019615-7520
• Status: Completed
• Start date: July 5, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Muscle Loss

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (8)

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. Review. — View 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. 2020 Aug 28. pii: S0261-5614(20)30438-6. doi: 10.1016/j.clnu.2020.08.022. [Epub ahead of print] — View 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. Review. — View Citation

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. — View Citation

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. Review. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Jul;40(5):742. — View Citation

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. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participant who died (Mortality)	Mortality at day 28, day 60, in the ICU and in the Hospital	Mortality at day 28 and day 60 (calculated from the first day of ICU admission)
Other	Survivors' long-term quality of life status	Survivors' 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).	6 months after ICU admission
Other	Katz Activities of Daily Living (ADL)	Survivors' 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.	6 months after ICU admission
Other	Lawton Instrumental Activities of Daily Living (IADL)	Survivors' 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.	6 months after ICU admission
Primary	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)
Primary	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	Ultrasound quadriceps echogenicity	Change in 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)
Secondary	Ultrasound quadriceps pennation angle	Change in 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)
Secondary	Ultrasound quadriceps fascicle length	Change in 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)
Secondary	Bioelectrical Impedance Analysis (BIA) phase angle	Change in whole body 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)

External Links

•   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