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Longitudinal Changes in Muscle Mass After Intensive Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05531305
Enrollment
35
Registered
2022-09-07
Start date
2022-09-26
Completion date
2023-06-06
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Muscle Loss

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

Interventions

DEVICEMuscle ultrasound

Standardized ultrasonographic measurement of quadriceps muscle layer thickness.

DEVICEIndirect calorimetry

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

DIAGNOSTIC_TESTHand dynamometry

Assessment of handgrip strength using hand dynamometry.

DIAGNOSTIC_TESTMRC Sum Score

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

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Quadriceps muscle layer thickness (MLT)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.

Secondary

MeasureTime frameDescription
Resting energy expenditure (REE)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.

Other

MeasureTime frameDescription
Handgrip strengthFrom 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.
MRC sum scoreFrom 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026