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CompletedNCT04711070Updated Feb 2, 2024

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

An observational study in Critical Illness Myopathy and Myopathy Critical Illness, sponsored by Sándor Beniczky. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Sándor Beniczky · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Critical Illness Myopathy
  • Myopathy Critical Illness

Keywords

  • Critical Illness Myopathy
  • Muscle Velocity Recovery Cycles
  • Intensive Care Unit
  • Sepsis
  • Diagnosis
  • Pathophysiology
03

In context

Muscular Diseases

280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 111 observational studies indexed under Muscular Diseases.

Browse Muscular Diseases studies →

Lead sponsor

Sándor Beniczky is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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/.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with sepsis

    Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test

  • Patients with chronic renal failure
  • Healthy control
06

What researchers measure

Primary outcomes

  1. Muscle relative refractory period (MRRP)

    Measurement of changes in muscle membrane properties by MVRCs.

    Time frame: 12 weeks

  2. Early supernormality (ESN)

    Measurement of changes in muscle membrane properties by MVRCs.

    Time frame: 12 weeks

Secondary outcomes

  1. Late supernormality (LSN)

    Measurement of changes in muscle membrane properties by MVRCs.

    Time frame: 12 weeks

  2. Extra late supernormality (XLSN)

    Measurement of changes in muscle membrane properties by MVRCs.

    Time frame: 12 weeks

07

Study locations

2 sites
  • Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
    Aarhus C, 8000, Denmark
  • Department of Clinical Neurophysiology, Aarhus University Hospital
    Aarhus C, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04711070
Lead sponsor
Sándor Beniczky
Collaborators
Danish Council for Independent Research, University of Aarhus, Søster og Verner Lipperts Fond
Responsible party
Sándor Beniczky (Professor, Aarhus University Hospital) — Sponsor-investigator
First posted
Jan 15, 2021
Start date
Jan 4, 2021
Primary completion
Dec 31, 2022
Completion
Feb 1, 2024
Last update
Feb 2, 2024

Study contacts

Hatice H Tankisi, MD, PhD
study chair · Aarhus University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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