Longitudinal Changes in Muscle Mass After Intensive Care

NCT05531305 | Completed

• 1 other identifier: K 2022-6873
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill patients often suffer from dramatic muscle loss while in the ICU. Recovery of muscle structure and function have been proposed as core outcome measures for interventional studies in ICU survivors. Ultrasound is an accessible and validated tool to monitor muscle mass over time, with quadriceps muscle layer thickness (MLT) corresponding well to more invasive or cumbersome modalities. In order to design adequately powered studies investigating the effects of nutritional or metabolic interventions on post-ICU recovery, an estimate of the population standard deviation in MLT change over time is required. Currently there is a paucity of data describing changes in muscle mass during the subsequent period of hospitalization in ICU survivors. The aim of this study is to estimate the mean change and standard deviation in quadriceps MLT over time, in patients discharged alive from intensive care. Patients will be followed until hospital discharge or up to 28 days after ICU discharge. Interactions with nutritional intake, inflammation and metabolic rate will be analyzed for hypothesis-generating purposes.

Conditions

Critical Illness; Muscle Loss

Outcome Measures

Primary Outcomes (1)

• Quadriceps muscle layer thickness (MLT)

  Change in quadriceps MLT (mean +/- standard deviation) over time.

  From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first measurement is performed within 72 hours after ICU discharge and repeated every 3-5 days.

Secondary Outcomes (1)

• Resting energy expenditure (REE)

  From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first measurement is performed within 72 hours after ICU discharge and repeated every 3-5 days.

Other Outcomes (2)

• Handgrip strength

  From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first measurement is performed within 72 hours after ICU discharge and repeated every 3-5 days.

• MRC sum score

  From ICU discharge to either hospital discharge or up to 28 days after ICU discharge, whichever comes first. The first assessment is performed within 72 hours after ICU discharge and repeated every 3-5 days.

Study Arms (1)

Study intervention

EXPERIMENTAL

Device: Muscle ultrasound; Device: Indirect calorimetry; Diagnostic Test: Hand dynamometry; Diagnostic Test: MRC Sum Score

Interventions

Muscle ultrasound DEVICE

Standardized ultrasonographic measurement of quadriceps muscle layer thickness.

Study intervention

Indirect calorimetry DEVICE

Non-invasive measurement of resting energy expenditure using the Q-NRG metabolic monitor with hood and canopy.

Study intervention

Hand dynamometry DIAGNOSTIC_TEST

Assessment of handgrip strength using hand dynamometry.

Study intervention

MRC Sum Score DIAGNOSTIC_TEST

Assessment of muscle function/limb strength using the Medical Research Council sum score (12-60 points).

Study intervention

Eligibility Criteria

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

You may qualify if:

• ≥18 years old.
• ICU length of stay ≥3 days.
• Expected to be discharged alive within 72 hours.

You may not qualify if:

• Lack of informed consent.
• Limitations in treatment to best supportive care (not expected to survive hospitalization).

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Huddinge, Stockholm County, 14186, Sweden

Location

Related Publications (7)

• Davies TW, van Gassel RJJ, van de Poll M, Gunst J, Casaer MP, Christopher KB, Preiser JC, Hill A, Gundogan K, Reintam-Blaser A, Rousseau AF, Hodgson C, Needham DM, Castro M, Schaller S, McClelland T, Pilkington JJ, Sevin CM, Wischmeyer PE, Lee ZY, Govil D, Li A, Chapple L, Denehy L, Montejo-Gonzalez JC, Taylor B, Bear DE, Pearse R, McNelly A, Prowle J, Puthucheary ZA. Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE). Crit Care. 2022 Aug 6;26(1):240. doi: 10.1186/s13054-022-04113-x.

  PMID: 35933433 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

• Preiser JC, Ichai C, Orban JC, Groeneveld AB. Metabolic response to the stress of critical illness. Br J Anaesth. 2014 Dec;113(6):945-54. doi: 10.1093/bja/aeu187. Epub 2014 Jun 26.

  PMID: 24970271 BACKGROUND

• Fischer A, Hertwig A, Hahn R, Anwar M, Siebenrock T, Pesta M, Liebau K, Timmermann I, Brugger J, Posch M, Ringl H, Tamandl D, Hiesmayr M; USVALID Collaboration Group. Validation of bedside ultrasound to predict lumbar muscle area in the computed tomography in 200 non-critically ill patients: The USVALID prospective study. Clin Nutr. 2022 Apr;41(4):829-837. doi: 10.1016/j.clnu.2022.01.034. Epub 2022 Feb 11.

  PMID: 35263692 BACKGROUND

• Ridley EJ, Parke RL, Davies AR, Bailey M, Hodgson C, Deane AM, McGuinness S, Cooper DJ. What Happens to Nutrition Intake in the Post-Intensive Care Unit Hospitalization Period? An Observational Cohort Study in Critically Ill Adults. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):88-95. doi: 10.1002/jpen.1196. Epub 2018 Jun 20.

  PMID: 29924393 BACKGROUND

• Schuetz P, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Tribolet P, Bregenzer T, Braun N, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Mattmann S, Thomann R, Brand C, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B. Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. Lancet. 2019 Jun 8;393(10188):2312-2321. doi: 10.1016/S0140-6736(18)32776-4. Epub 2019 Apr 25.

  PMID: 31030981 BACKGROUND

• Sundstrom Rehal M, Sebghati Sparrfelt C, Lajewska N, Fischer A, Kilsand K, Helleberg J, Habel H, Rooyackers O. Longitudinal changes in muscle mass after ICU discharge: A prospective observational cohort study. Clin Nutr. 2025 Nov;54:53-61. doi: 10.1016/j.clnu.2025.09.004. Epub 2025 Sep 18.

  PMID: 41027230 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Interventions

Calorimetry, Indirect

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

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Martin Sundström Rehal, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Olav Rooyackers, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 26, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)