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

NCT04711070 | Completed

• 1 other identifier: MCIM
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness Myopathy; Myopathy Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Muscle relative refractory period (MRRP)

  Measurement of changes in muscle membrane properties by MVRCs.

  12 weeks

• Early supernormality (ESN)

  Measurement of changes in muscle membrane properties by MVRCs.

  12 weeks

Secondary Outcomes (2)

• Late supernormality (LSN)

  12 weeks

• Extra late supernormality (XLSN)

  12 weeks

Study Arms (3)

Patients with sepsis

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

Patients with chronic renal failure

Healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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/.

You may qualify if:

• Patients: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sándor Beniczky: lead
• Danish Council for Independent Research: collaborator
• University of Aarhus: collaborator
• Søster og Verner Lipperts Fond: collaborator

Study Sites (2)

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Department of Clinical Neurophysiology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice H Tankisi, MD, PhD

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 4, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

DK (2)