Longitudinal Changes in Muscle Mass After Intensive Care

NCT05531305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-10-24

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Martin Sundström Rehal, MD PhD · Karolinska University Hospital

  • Olav Rooyackers, PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2023-06-06
Completion
2023-06-06

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531305 on ClinicalTrials.gov