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

NCT06697470 | Recruiting DMC

• 1 other identifier: P2024/372
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Weakness Acquired in the ICU; Muscle Wasting; Edema; Fluid Overload; Critical Illness; Intensive Care Unit (ICU) Patients

Keywords

Muscle thickness; Subcutaneous tissue; Ultrasound; Bioelectrical impedance analysis; BIA; Fluid balance; ICU (intensive care unit); Muscle strength; MRC-sum score; Grip strength; Edema assessment; Critical care; Skeletal muscle; Hydration status; Muscle echogenicity; ICU-acquired weakness; Fluid compartments; Extracellular water; Intracellular water; Body composition; Bedside ultrasound; Fluid management; Early mobilization; Volume overload; Tissue edema; Body water compartments; Length of ICU stay; Muscle quality

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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)

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

Secondary Outcomes (1)

• Grip Strength Assessment

  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.

Study Arms (1)

Critically Ill Patients in ICU

This cohort consists of adult patients aged over 18 years who are admitted to the ICU at Epicura Hornu Hospital between October 14, 2024, and November 15, 2024 (to be updated). The study will investigate muscle thickness variations and fluid balance using ultrasound and bioelectrical impedance analysis (BIA). Informed consent will be obtained from the patients or their legal representatives.

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

Interventions

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.

Critically Ill Patients in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients in post-operative or other surveillance with an expected ICU stay of less than 48 hours.
• Presence of skin conditions (e.g., wounds or ulcers) that hinder ultrasound measurements or the application of skin electrodes.
• Pregnancy.
• Presence of an implanted pacemaker or defibrillator.

Sponsors & Collaborators

• Dr F Duprez: lead

Study Sites (2)

Epicura site Hornu

Boussu, Hainaut, 7301, Belgium

RECRUITING

Epicura site Hornu

Boussu, 7301, Belgium

RECRUITING

Related Publications (14)

• Gonzalez-Seguel F, Pinto-Concha JJ, Rios-Castro F, Silva-Gutierrez A, Camus-Molina A, Mayer KP, Parry SM. Evaluating a Muscle Ultrasound Education Program: Theoretical Knowledge, Hands-on Skills, Reliability, and Satisfaction of Critical Care Physiotherapists. Arch Rehabil Res Clin Transl. 2021 Jul 13;3(3):100142. doi: 10.1016/j.arrct.2021.100142. eCollection 2021 Sep.

  PMID: 34589692 BACKGROUND

• Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

  PMID: 26211979 BACKGROUND

• Grimm A, Teschner U, Porzelius C, Ludewig K, Zielske J, Witte OW, Brunkhorst FM, Axer H. Muscle ultrasound for early assessment of critical illness neuromyopathy in severe sepsis. Crit Care. 2013 Oct 7;17(5):R227. doi: 10.1186/cc13050.

  PMID: 24499688 BACKGROUND

• Formenti P, Umbrello M, Coppola S, Froio S, Chiumello D. Clinical review: peripheral muscular ultrasound in the ICU. Ann Intensive Care. 2019 May 17;9(1):57. doi: 10.1186/s13613-019-0531-x.

  PMID: 31101987 BACKGROUND

• Malbrain ML, Huygh J, Dabrowski W, De Waele JJ, Staelens A, Wauters J. The use of bio-electrical impedance analysis (BIA) to guide fluid management, resuscitation and deresuscitation in critically ill patients: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):381-91. doi: 10.5603/AIT.2014.0061.

  PMID: 25432557 BACKGROUND

• Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012.

  PMID: 15556267 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Reynolds PM, Stefanos S, MacLaren R. Restrictive resuscitation in patients with sepsis and mortality: A systematic review and meta-analysis with trial sequential analysis. Pharmacotherapy. 2023 Feb;43(2):104-114. doi: 10.1002/phar.2764. Epub 2023 Jan 21.

  PMID: 36625778 BACKGROUND

• Murphy CV, Schramm GE, Doherty JA, Reichley RM, Gajic O, Afessa B, Micek ST, Kollef MH. The importance of fluid management in acute lung injury secondary to septic shock. Chest. 2009 Jul;136(1):102-109. doi: 10.1378/chest.08-2706. Epub 2009 Mar 24.

  PMID: 19318675 BACKGROUND

• Fazzini B, Markl T, Costas C, Blobner M, Schaller SJ, Prowle J, Puthucheary Z, Wackerhage H. The rate and assessment of muscle wasting during critical illness: a systematic review and meta-analysis. Crit Care. 2023 Jan 3;27(1):2. doi: 10.1186/s13054-022-04253-0.

  PMID: 36597123 BACKGROUND

• Paolo F, Valentina G, Silvia C, Tommaso P, Elena C, Martin D, Marini John J, Davide C. The possible predictive value of muscle ultrasound in the diagnosis of ICUAW in long-term critically ill patients. J Crit Care. 2022 Oct;71:154104. doi: 10.1016/j.jcrc.2022.154104. Epub 2022 Jul 4.

  PMID: 35797827 BACKGROUND

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 BACKGROUND

• Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.

  PMID: 26457181 BACKGROUND

• Latronico N, Rasulo FA, Eikermann M, Piva S. Illness Weakness, Polyneuropathy and Myopathy: Diagnosis, treatment, and long-term outcomes. Crit Care. 2023 Nov 13;27(1):439. doi: 10.1186/s13054-023-04676-3.

  PMID: 37957759 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy; Edema; Critical Illness

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Cheryl E HICKMANN, PhD

CONTACT

+32488381526; c.hickmannopazo@condorcet.be

Frederic Duprez, Phd

CONTACT

0032475857104; frederic.duprez@condorcet.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist / Professor at Provincial High School Condorcet (PhD) & Director of the Unité de recherche et d'innovation Condorcet EpiCURA (URICE)

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 20, 2024
• Study Start: October 21, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

BE (2)