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Longitudinal Changes in Muscle Mass After Intensive Care

Primary Purpose

Critical Illness, Muscle Loss

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Muscle ultrasound
Indirect calorimetry
Hand dynamometry
MRC Sum Score
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study intervention

Arm Description

Outcomes

Primary Outcome Measures

Quadriceps muscle layer thickness (MLT)
Change in quadriceps MLT (mean +/- standard deviation) over time.

Secondary Outcome Measures

Resting energy expenditure (REE)
Change in REE over time.

Full Information

First Posted
September 2, 2022
Last Updated
October 23, 2023
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05531305
Brief Title
Longitudinal Changes in Muscle Mass After Intensive Care
Official Title
Longitudinal Changes in Muscle Mass After Intensive Care: a Pilot Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 6, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Muscle Loss

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Muscle ultrasound
Intervention Description
Standardized ultrasonographic measurement of quadriceps muscle layer thickness.
Intervention Type
Device
Intervention Name(s)
Indirect calorimetry
Intervention Description
Non-invasive measurement of resting energy expenditure using the Q-NRG metabolic monitor with hood and canopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
Hand dynamometry
Intervention Description
Assessment of handgrip strength using hand dynamometry.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRC Sum Score
Intervention Description
Assessment of muscle function/limb strength using the Medical Research Council sum score (12-60 points).
Primary Outcome Measure Information:
Title
Quadriceps muscle layer thickness (MLT)
Description
Change in quadriceps MLT (mean +/- standard deviation) over time.
Time Frame
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 Outcome Measure Information:
Title
Resting energy expenditure (REE)
Description
Change in REE over time.
Time Frame
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 Pre-specified Outcome Measures:
Title
Handgrip strength
Description
Change in handgrip strength, as assessed by hand dynamometry, over time.
Time Frame
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.
Title
MRC sum score
Description
Change in MRC sum score over time.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years old. ICU length of stay ≥3 days. Expected to be discharged alive within 72 hours. Exclusion Criteria: Lack of informed consent. Limitations in treatment to best supportive care (not expected to survive hospitalization).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Sundström Rehal, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olav Rooyackers, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska University Hospital
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35933433
Citation
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.
Results Reference
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PubMed Identifier
24108501
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. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
Results Reference
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PubMed Identifier
24970271
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Results Reference
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Longitudinal Changes in Muscle Mass After Intensive Care

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