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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04711070
Other study ID # MCIM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date February 1, 2024

Study information

Verified date February 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Critical illness myopathy (CIM) is a disabling condition that develops in critically ill patients. The syndrome is not only a cause of prolonged intensive care hospitalisation but also a main reason for delayed recovery. Critical illness myopathy presents as diffuse muscle weakness and failure to wean from mechanical ventilation. The pathogenesis of CIM is unclear. The proposed mechanisms for critical illness myopathy include muscle membrane depolarization, circulating depolarizing factor, and an endotoxin that reduces muscle sodium channel availability at depolarized membrane potentials. The electrophysiological diagnosis of CIM diagnosis is done by electromyography (EMG). In order to be able to detect changes in EMG, more than 2-3 weeks' time is required. Moreover the findings resemble other myopathies and are unspecific. EMG studies in paralysed muscles and sometimes unconscious patients is difficult or even impossible Since the 1950s, it has been attempted to investigate the muscle cell membrane properties, but it has not been possible to develop a clinically applicable diagnostic method. The novel electrophysiological method MVRCs is a possible future diagnostic method. It's more sensitive to muscle cell membrane changes than existing methods and it is simple enough to use in multiple clinical settings. The objective of this study is to investigate the utility of MVRCs in the early diagnosis of critical illness myopathy by investigating the muscle membrane properties in sepsis patients, who are in risk of developing CIM. In addition, this will contribute to a better understanding of the pathophysiology of critical illness myopathy. The study will enrol 70 participants in total, divided in to 2 groups of 20 patients aged ≥18 years; 1) patients with sepsis at intensive care units and 2) patients with chronic renal failure and uremia, and 30 sex- and aged-matched healthy participants. All subjects are to undergo neurological examinations, electromyography, nerve conduction studies, direct muscle stimulation and MVRCs. Blood tests will be taken in all patients. Patients with sepsis will be examined every week in 3 weeks. The presence of probable CIM will be determined on the 4th examination. Healthy participants and patients with chronic renal failure will only be examined in 1 occasion. The primary outcomes will be MVRCs parameters which will be compared between patients and healthy participants. Furthermore, MVRCs parameters will be correlated to blood sample results.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date February 1, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more. Exclusion Criteria: Patients and controls: - Earlier peripheral nervous system disease - History of malignancy, diabetes mellitus, alcoholism, medicine or other causes of polyneuropathy or myopathy - Bleeding tendency or anticoagulation therapy

Study Design


Locations

Country Name City State
Denmark Department of Anaesthesiology and Intensive Care, Aarhus University Hospital Aarhus C
Denmark Department of Clinical Neurophysiology, Aarhus University Hospital Aarhus C

Sponsors (4)

Lead Sponsor Collaborator
Sándor Beniczky Danish Council for Independent Research, Søster og Verner Lipperts Fond, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle relative refractory period (MRRP) Measurement of changes in muscle membrane properties by MVRCs. 12 weeks
Primary Early supernormality (ESN) Measurement of changes in muscle membrane properties by MVRCs. 12 weeks
Secondary Late supernormality (LSN) Measurement of changes in muscle membrane properties by MVRCs. 12 weeks
Secondary Extra late supernormality (XLSN) Measurement of changes in muscle membrane properties by MVRCs. 12 weeks
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