Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr F Duprez

About this trial

This cross-sectional study aims to investigate the relationship between variations in muscle thickness and subcutaneous tissue, measured by ultrasound, and fluid compartments, evaluated using bioelectrical impedance analysis (BIA), in critically ill patients in the intensive care unit (ICU). Critically ill patients frequently experience muscle wasting and tissue edema due to a combination of inflammation, immobilization, and aggressive fluid resuscitation protocols designed to counteract hemodynamic instability.

Ultrasound is widely used to monitor muscle thickness because it is fast, non-invasive, and repeatable. However, muscle thickness measurements during the first days of ICU admission may be influenced by fluid overload, which causes edema and might lead to an overestimation of actual muscle mass. Bioelectrical impedance analysis (BIA) is a complementary tool that assesses both intra- and extracellular fluid compartments. This study aims to correlate daily fluid balance with changes in muscle thickness and subcutaneous tissue measured by ultrasound, and to determine if BIA can accurately reflect fluid status and potentially identify edema in these patients.

Furthermore, at ICU discharge, patients' muscle strength will be assessed using both the MRC-sum score (0-60) and handgrip strength (using a Jamar dynamometer), to investigate whether the presence of edema at discharge correlates with muscle strength deficits. Data collection will occur daily, tracking fluid balance, clinical parameters, and body weight, alongside ultrasound and BIA measurements in a standardized position. The study will help clarify the interactions between fluid management, muscle mass changes, and clinical outcomes in critically ill patients, providing valuable insight into early rehabilitation strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged over 18 years.

Patients present and admitted to the ICU at Epicura Hornu Hospital between October 14, 2024, and November 15, 2024 (to be updated).

Informed consent to participate in the study has been signed by the patient or their legal representative.

Disqualifiers

Patients in post-operative or other surveillance with an expected ICU stay of less than 48 hours.

Patients for whom a decision to withdraw therapy has been made prior to inclusion.

Presence of skin conditions (e.g., wounds or ulcers) that hinder ultrasound measurements or the application of skin electrodes.

Pregnancy.

Trial population

The study population will consist of critically ill adult patients aged over 18 years, admitted to the Intensive Care Unit (ICU) at the Centre Hospitalier Epicura Hornu between October 14, 2024, and November 15, 2024 (to be updated). Participants will include individuals who have provided informed consent to participate in the study or whose legal representatives have signed on their behalf. The cohort will represent a diverse range of medical conditions requiring intensive care, and all participants will be monitored for muscle thickness variation and fluid balance throughout their ICU stay.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound and Bioelectrical Impedance Analysis for Muscle Thickness and Fluid Balance Assessment Translation

    Device

    This intervention involves the use of ultrasound and bioelectrical impedance analysis (BIA) to monitor changes in muscle thickness and assess fluid balance in critically ill patients. Measurements will be taken daily during the patients' ICU stay, with a focus on rectus femoris, tibialis anterior, and biceps brachii muscles, as well as total body fluid compartments. The study aims to explore correlations between muscle thickness variations, fluid balance, and patient outcomes.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Critically Ill Patients in ICU1 intervention

Trial outcomes

Primary outcomes

1

Muscle Thickness Variation Measured by Ultrasound (US)

Daily change in muscle thickness assessed by ultrasound (e.g., rectus femoris, tibialis anterior, and biceps brachii) from ICU admission to discharge. Muscle thickness will be measured in millimeters (mm) to evaluate muscle loss during the ICU stay. Unit of Measure: Millimeters (mm)

Time frame
Daily from the date of ICU admission until ICU discharge or up to a maximum of 28 days.
2

Fluid Balance Using Bioelectrical Impedance Analysis (BIA)

Daily change in total body water, extracellular water, and intracellular water assessed by bioelectrical impedance analysis (BIA) from ICU admission to discharge. Fluid compartments will be measured in liters (L), and the values will provide insights into fluid balance and its relationship to muscle changes during critical illness. Unit of Measure: Liters (L)

Time frame
Daily from the date of ICU admission until ICU discharge or up to a maximum of 28 days.

Secondary outcomes

1

Grip Strength Assessment

This outcome measure evaluates grip strength using a dynamometer (Jamar hand dynamometer) at the time of ICU discharge. Grip strength will be assessed in the dominant hand, with three repetitions recorded to determine the maximum strength output. This measure will provide insights into the functional status and muscular strength of patients as they transition out of the ICU. Unit of Measure: Pounds (lb)

Time frame
Grip strength will be assessed once at the time of ICU discharge, which is expected to occur within 2 to 28 days of ICU admission.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr F Duprez

Lead sponsor

Laboratory of Movement, Condorcet, Tournai, Belgium

Sponsor institution