Body Impedance Analysis to Detect ICUAW

Critical Illness Clinical Trial

— BIAMI  

Official title:

Body Impedance Analysis to Detect Muscle Strength Associated With ICU Acquired Weakness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572138
• Other study ID #: BIAMI
• Status: Completed
• Start date: February 8, 2023
• Est. completion date: January 28, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated.

The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Description:

Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. It develops in approximately 40% of all ICU patients, which corresponds to at least 1.2 million patients annually in Germany. All these patients face a wide spectrum of sequelae and increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after ICU admission.

ICUAW is currently diagnosed by the MRC score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). Manual muscle testing (MMT) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. In addition, there is a possible discrepancy by different observers. As a result, early detection of ICUAW may be inadequate in most patients and unreliable during critical illness.

Measurement by BIA is reproducible, so differences in measurement can be attributed to changes in clinical condition. Body impedance analysis thus demonstrates a means of objective measurement.

Thus, the study aims to counteract the long-term consequences of ICUAW through early detection of ICUAW by allowing countermeasures to be taken earlier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years with ventilatory support within 36 hours from ICU admission.

Exclusion Criteria:

• With a language barrier

• Patients with pacemaker or other electronic implant

• Expected death or discontinuation of life-sustaining measures.

• Not walking independently before hospitalization (gait aids allowed)

• Allergy to electrode gel

• BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages

Related Conditions & MeSH terms

• Critical Illness

Intervention

Diagnostic Test:
• Body Impedance Analysis
Body Impedance Analysis

Locations

Country	Name	City	State
Germany	Charité - Univiversitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Appleton RT, Kinsella J, Quasim T. The incidence of intensive care unit-acquired weakness syndromes: A systematic review. J Intensive Care Soc. 2015 May;16(2):126-136. doi: 10.1177/1751143714563016. Epub 2014 Dec 18. — View Citation

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859. — View Citation

Fan E, Cheek F, Chlan L, Gosselink R, Hart N, Herridge MS, Hopkins RO, Hough CL, Kress JP, Latronico N, Moss M, Needham DM, Rich MM, Stevens RD, Wilson KC, Winkelman C, Zochodne DW, Ali NA; ATS Committee on ICU-acquired Weakness in Adults; American Thoracic Society. An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults. Am J Respir Crit Care Med. 2014 Dec 15;190(12):1437-46. doi: 10.1164/rccm.201411-2011ST. — View Citation

Gijsen M, Simons E, De Cock P, L N G Malbrain M, Wauters J, Spriet I. Reproducibility of fluid status measured by bioelectrical impedance analysis in healthy volunteers: a key requirement to monitor fluid status in the intensive care unit. Anaesthesiol Intensive Ther. 2021;53(3):193-199. doi: 10.5114/ait.2021.105826. — View Citation

Hough CL, Lieu BK, Caldwell ES. Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement. Crit Care. 2011;15(1):R43. doi: 10.1186/cc10005. Epub 2011 Jan 28. — View Citation

Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004. — View Citation

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. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

Savalle M, Gillaizeau F, Maruani G, Puymirat E, Bellenfant F, Houillier P, Fagon JY, Faisy C. Assessment of body cell mass at bedside in critically ill patients. Am J Physiol Endocrinol Metab. 2012 Aug 1;303(3):E389-96. doi: 10.1152/ajpendo.00502.2011. Epub 2012 May 29. — View Citation

Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22. — View Citation

Wollersheim T, Woehlecke J, Krebs M, Hamati J, Lodka D, Luther-Schroeder A, Langhans C, Haas K, Radtke T, Kleber C, Spies C, Labeit S, Schuelke M, Spuler S, Spranger J, Weber-Carstens S, Fielitz J. Dynamics of myosin degradation in intensive care unit-acquired weakness during severe critical illness. Intensive Care Med. 2014 Apr;40(4):528-38. doi: 10.1007/s00134-014-3224-9. Epub 2014 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation: Skeletal muscle mass and MRC-Score	The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score.	till Day 30
Secondary	Correlation CSA and Skeletal muscle mass	Cross sectional area of muscle ultrasound (M. rectus femoris) and Skeletal muscle mass (SMM) measured by BIA	till Day 30
Secondary	UCR : MRC correlation	Correlation of urea-creatinine ratio in blood with MRC score.	till Day 30
Secondary	Kreatinin : MRC correlation	Correlation of creatinine in blood with MRC score.	till Day 30
Secondary	IMS during the ICU stay	achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)	till Day 30 or ICU discharge
Secondary	ICU mortality	Mortality during ICU stay	till Day 30
Secondary	Duration of Mechanical ventilation	Duration of invasive mechanical ventilator dependency	till Day 30
Secondary	Hospital mortality	Mortality during Hospital stay	till Day 30
Secondary	ICU-LOS	Length of stay in the ICU	till Day 30 (till ICU discharge)
Secondary	Hospital LOS	Length of stay in the hospital	till Day 30 (till hospital discharge)
Secondary	in-hospital mortality	Mortality during the Hospital stay	till Day 30 (till hospital discharge)