Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 13, 2021
First Posted Date January 15, 2021
Last Update Posted Date January 15, 2021
Actual Study Start Date January 4, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2021)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 13, 2021)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - MVRCs
Official Title Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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/.

Condition
  • Critical Illness Myopathy
  • Myopathy Critical Illness
Intervention Not Provided
Study Groups/Cohorts
  • Patients with sepsis
    Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test
  • Patients with chronic renal failure
  • Healthy control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 13, 2021)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lotte H Larsen, Stud.med. 004523366988 lottlr@rm.dk
Contact: Hatice Tankisi, MD, PhD 004578462431 hatitank@rm.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04711070
Other Study ID Numbers MCIM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sándor Beniczky, Aarhus University Hospital
Study Sponsor Sándor Beniczky
Collaborators
  • Danish Council for Independent Research
  • University of Aarhus
  • Søster og Verner Lipperts Fond
Investigators
Study Chair: Hatice H Tankisi, MD, PhD Aarhus Universitetshospital
PRS Account Aarhus University Hospital
Verification Date January 2021