CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Muscle ultrasound +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05531305
NCT05531305N/ACompleted

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

Karolinska University Hospital·interventional·Posted Sep 7, 2022·Updated Oct 24, 2023

In Brief

A clinical study evaluating Muscle ultrasound, Indirect calorimetry, and 2 other interventions for Critical Illness and Muscle Loss. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 7, 2022
Enrollment StartSep 26, 2022
Primary CompletionJun 6, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.8 years ago

Interventions

Muscle ultrasounddevice

Standardized ultrasonographic measurement of quadriceps muscle layer thickness.

Indirect calorimetrydevice

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

Hand dynamometryother

Assessment of handgrip strength using hand dynamometry.

MRC Sum Scoreother

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