Critical Illness MyopathyNCT04711070
Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - MVRCs
An observational study of Critical Illness Myopathy and Myopathy Critical Illness, run by Sándor Beniczky at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness Myopathy, Myopathy Critical Illness
- How many people
- 42 participants
- Where
- 2 sitesDenmark
- Study dates
- 4 Jan 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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/.
Who may be able to join
- Patients: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
Aarhus C, 8000
Department of Clinical Neurophysiology, Aarhus University Hospital
Aarhus C, 8000
About this study
Official title: Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)
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.
Read more
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.
- Keywords
- Critical Illness Myopathy, Muscle Velocity Recovery Cycles, Intensive Care Unit, Sepsis, Diagnosis, Pathophysiology
- Medical subject headings
- Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sepsis | Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test | |
| Patients with chronic renal failure | Not described | |
| Healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle relative refractory period (MRRP)
Measurement of changes in muscle membrane properties by MVRCs.
Measured: 12 weeks
Early supernormality (ESN)
Measurement of changes in muscle membrane properties by MVRCs.
Measured: 12 weeks
Secondary outcomes (2)
Late supernormality (LSN)
Measurement of changes in muscle membrane properties by MVRCs.
Measured: 12 weeks
Extra late supernormality (XLSN)
Measurement of changes in muscle membrane properties by MVRCs.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start4 Jan 2021
- Primary completion31 Dec 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sándor Beniczky
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Council for Independent Research, University of Aarhus, Søster og Verner Lipperts Fond
- Responsible party
- Sponsor-investigator, Sándor Beniczky, Aarhus University Hospital
- Investigators
- Hatice H Tankisi, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711070
- Sponsor's protocol ID
- MCIM
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)
- ClinicalTrials.gov ID
- NCT04711070
- Acronym / sponsor ID
- MCIM
- Keywords
- Critical Illness Myopathy, Muscle Velocity Recovery Cycles, Intensive Care Unit, Sepsis, Diagnosis, Pathophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sándor BeniczkyUniversity, hospital or other
- Collaborators
- Danish Council for Independent Research, University of Aarhus, Søster og Verner Lipperts Fond
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with sepsis | – | –Muscle velocity recovery cycles, electromyography, nerve conduction studies, direct musclestimulation, blood test |
| Patients with chronic renal failure | – | – |
| Healthy control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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/.
Key inclusion criteria (1 listed)
- Patients: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more.
Key exclusion criteria (4 listed)
- Earlier peripheral nervous system disease
- History of malignancy, diabetes mellitus, alcoholism, medicine or other causes of polyneuropathy or myopathy
- Bleeding tendency or anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Late supernormality (LSN)
Time frame: 12 weeks
Extra late supernormality (XLSN)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice H Tankisi, MD, PhD study chair
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness Myopathy and Myopathy Critical Illness, run by Sándor Beniczky at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle relative refractory period (MRRP) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.