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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
Sponsor:
Collaborators:
Danish Council for Independent Research
University of Aarhus
Søster og Verner Lipperts Fond
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

Study Description
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Brief 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.


Condition or disease
Critical Illness Myopathy Myopathy Critical Illness

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders

Groups and Cohorts
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Group/Cohort
Patients with sepsis
Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test
Patients with chronic renal failure
Healthy control


Outcome Measures
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Primary Outcome Measures :
  1. Muscle relative refractory period (MRRP) [ Time Frame: 12 weeks ]
    Measurement of changes in muscle membrane properties by MVRCs.

  2. Early supernormality (ESN) [ Time Frame: 12 weeks ]
    Measurement of changes in muscle membrane properties by MVRCs.


Secondary Outcome Measures :
  1. Late supernormality (LSN) [ Time Frame: 12 weeks ]
    Measurement of changes in muscle membrane properties by MVRCs.

  2. Extra late supernormality (XLSN) [ Time Frame: 12 weeks ]
    Measurement of changes in muscle membrane properties by MVRCs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients: Recruited from patients hospitalized in Intensive Care Units at the Department of Anaesthesiology and Intensive Care, Aarhus University Hospital.

Healthy participants: Recruitment posters at Aarhus University, Aarhus University Hospital and at http://www.forsoegsperson.dk/.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lotte H Larsen, Stud.med. 004523366988 lottlr@rm.dk
Contact: Hatice Tankisi, MD, PhD 004578462431 hatitank@rm.dk

Locations
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Denmark
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
Sponsors and Collaborators
Sándor Beniczky
Danish Council for Independent Research
University of Aarhus
Søster og Verner Lipperts Fond
Investigators
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Study Chair: Hatice H Tankisi, MD, PhD Aarhus Universitetshospital
More Information
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Responsible Party: Sándor Beniczky, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04711070    
Other Study ID Numbers: MCIM
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sándor Beniczky, Aarhus University Hospital:
Critical Illness Myopathy
Muscle Velocity Recovery Cycles
Intensive Care Unit
 Sepsis
Diagnosis
Pathophysiology
Additional relevant MeSH terms:
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Muscular Diseases
Critical Illness
Disease Attributes
Pathologic Processes
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases