Longitudinal Changes in Muscle Mass After Intensive Care

October 23, 2023 updated by: Martin Sundstrom Rehal, Karolinska University Hospital

Longitudinal Changes in Muscle Mass After Intensive Care: a Pilot Feasibility Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Huddinge, Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study intervention
Device: Muscle ultrasound
Standardized ultrasonographic measurement of quadriceps muscle layer thickness.
Device: Indirect calorimetry
Non-invasive measurement of resting energy expenditure using the Q-NRG metabolic monitor with hood and canopy.
Diagnostic test: Hand dynamometry
Assessment of handgrip strength using hand dynamometry.
Diagnostic test: MRC Sum Score
Assessment of muscle function/limb strength using the Medical Research Council sum score (12-60 points).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps muscle layer thickness (MLT)
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting energy expenditure (REE)
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.
Change in REE 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
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.
Change in handgrip strength, as assessed by hand dynamometry, 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.
MRC sum score
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.
Change in MRC sum score over time.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Martin Sundström Rehal, MD PhD, Karolinska University Hospital
  • Study Chair: Olav Rooyackers, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Actual)

June 6, 2023

Study Completion (Actual)

June 6, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K 2022-6873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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