Longitudinal Changes in Muscle Mass After Intensive Care
NCT ID: NCT05531305
Last Updated: 2023-10-24
Study Results
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Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-09-26
2023-06-06
Brief Summary
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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.
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Detailed Description
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Rapid and severe muscle loss is a common feature in intensive care \[1\]. Nutritional support is provided with the intention of preventing excessive muscle protein breakdown, but the evidence that higher energy or protein intake can mitigate muscle wasting in the ICU is limited \[2\]. A potential explanation to these findings is the proinflammatory and catabolic state often associated with critical illness \[3\]. As long as a patient remains critically ill, the potential to promote anabolism and recovery may be limited.
It is well-documented that patients discharged from ICU often suffer from poor oral intake during hospital stay \[4,5\]. Optimizing nutritional support in the post-ICU period may therefore be a simple and cost-effective way of counteracting sarcopenia and improving health-related outcomes \[6\]. Currently there is a lack of published studies investigating the effect of nutritional interventions on lean body mass after intensive care. This may be due to the cumbersome and resource-intensive methods previously available for measuring body composition. In recent years, bedside ultrasound has become increasingly popular as a research tool for monitoring muscle loss over time. It has been validated against other radiological modalities, is non-invasive and accessible \[7\].
As there is a lack of literature describing sonographic changes in muscle mass over time in the post-ICU phase, data is needed to support a formal power calculation for interventional studies assessing muscle loss as a primary outcome measure. We therefore plan an observational longitudinal study to describe the change in quadriceps muscle layer thickness over time between ICU and hospital discharge.
Aim
The aims of this project are to 1) estimate the standard deviation of the change in quadriceps muscle layer thickness (MLT) over time, and 2) determine the feasibility of performing a longitudinal follow-up of MLT and energy expenditure in hospitalized patients after ICU discharge.
Hypothesis
In patients discharged alive from the ICU, there is a decrease in mean MLT over time during hospitalization
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study intervention
Muscle ultrasound
Standardized ultrasonographic measurement of quadriceps muscle layer thickness.
Indirect calorimetry
Non-invasive measurement of resting energy expenditure using the Q-NRG metabolic monitor with hood and canopy.
Hand dynamometry
Assessment of handgrip strength using hand dynamometry.
MRC Sum Score
Assessment of muscle function/limb strength using the Medical Research Council sum score (12-60 points).
Interventions
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Muscle ultrasound
Standardized ultrasonographic measurement of quadriceps muscle layer thickness.
Indirect calorimetry
Non-invasive measurement of resting energy expenditure using the Q-NRG metabolic monitor with hood and canopy.
Hand dynamometry
Assessment of handgrip strength using hand dynamometry.
MRC Sum Score
Assessment of muscle function/limb strength using the Medical Research Council sum score (12-60 points).
Eligibility Criteria
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Inclusion Criteria
* ICU length of stay ≥3 days.
* Expected to be discharged alive within 72 hours.
Exclusion Criteria
* Limitations in treatment to best supportive care (not expected to survive hospitalization).
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Martin Sundstrom Rehal
Principal Investigator
Principal Investigators
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Martin Sundström Rehal, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Olav Rooyackers, PhD
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Karolinska University Hospital
Huddinge, Stockholm County, Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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 Sep 18;54:53-61. doi: 10.1016/j.clnu.2025.09.004. Online ahead of print.
Other Identifiers
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K 2022-6873
Identifier Type: -
Identifier Source: org_study_id
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