Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - MVRCs

Critical Illness Myopathy Clinical Trial

Official title:

Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711070
• Other study ID #: MCIM
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy
• Muscular Diseases
• Myopathy Critical Illness

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