Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - MVRCs
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|ClinicalTrials.gov Identifier: NCT04711070|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
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.
|Condition or disease|
|Critical Illness Myopathy Myopathy Critical Illness|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)|
|Actual Study Start Date :||January 4, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Patients with sepsis
Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test
|Patients with chronic renal failure|
- Muscle relative refractory period (MRRP) [ Time Frame: 12 weeks ]Measurement of changes in muscle membrane properties by MVRCs.
- Early supernormality (ESN) [ Time Frame: 12 weeks ]Measurement of changes in muscle membrane properties by MVRCs.
- Late supernormality (LSN) [ Time Frame: 12 weeks ]Measurement of changes in muscle membrane properties by MVRCs.
- Extra late supernormality (XLSN) [ Time Frame: 12 weeks ]Measurement of changes in muscle membrane properties by MVRCs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711070
|Contact: Lotte H Larsen, Stud.firstname.lastname@example.org|
|Contact: Hatice Tankisi, MD, PhDemail@example.com|
|Department of Anaesthesiology and Intensive Care, Aarhus University Hospital||Recruiting|
|Aarhus C, Denmark, 8000|
|Contact: Alp Tankisi, MD, PhD|
|Contact: Stig E Dyrskog, MD, PhD|
|Department of Clinical Neurophysiology, Aarhus University Hospital||Not yet recruiting|
|Aarhus C, Denmark, 8000|
|Study Chair:||Hatice H Tankisi, MD, PhD||Aarhus Universitetshospital|