Muscle WeaknessNCT00893633
Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients
An observational study of Muscle Weakness and Critical Illness, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
Trial summary
The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness
- How many people
- 135 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2004to Jan 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from neurosurgical ICU in city clinical hospital
Who may be able to join
- Age: 16 years and older
- Acute primary cerebral pathology
- Mechanical ventilation
- Signs of systemic inflammatory response
- Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history
Who cannot join
- Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness
- Inability to perform high-grade nerve conduction studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit
The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.
Read the detailed description
Since 1984, the problem of critical illness neuromuscular abnormalities (CINMAs) has attracted considerable interest. According to these studies, CINMAs include the muscular weakness that accompanies critical illness resulting from polyneuropathy and/or myopathy and can be seen in 25-85% of cases of critically ill patients. Clinically, CINMAs present as symmetric flaccid tetraparesis and difficulty weaning off mechanical lung ventilation. However, these data are derived from treating non-specialized intensive care unit (ICU) patients. In this research, we wished to investigate CINMAs in neurocritical care patients. From day one of the patients' participation in the research and until a discharge from the ICU (or death), daily neurological surveys and weekly nerve conduction studies were performed. Based on the results of each nerve conduction study, an index of neuromuscular damage was noted to evaluate the severity of the CINMAs. Needle electromyography and muscle biopsy were not used
- Conditions
- Muscle Weakness, Critical Illness
- Keywords
- neuromuscular diseases, critical illness, mechanical ventilation, phrenic nerve, nerve conduction studies
- Medical subject headings
- Muscle Weakness, Critical Illness, Neuromuscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of critical illness neuromuscular abnormalities (CINMAs)
Measured: within the first week of mechanical ventilation
Secondary outcomes (3)
clinical and neurophysiological characteristics of CINMAs
Measured: within the first week of mechanical ventilation
influence оf phrenic nerve pathology on weaning from mechanical ventilation
Measured: during weaning period
dynamics of the neurophysiological characteristics of CINMAs
Measured: during stay in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMar 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Institute of the Brain, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- City Hospital No 40, Saint Petersburg, Russia
- Investigators
- Andrey M Alasheev, MD, PhD, Principal investigator, Clinical Institute of the Brain, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893633
- Sponsor's protocol ID
- CINMAs-2004
- Status last verified
- Jul 2009
- First submitted
- 5 May 2009
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00893633
- Acronym / sponsor ID
- CINMAs-2004
- Conditions
- Muscle Weakness, Critical Illness
- Keywords
- neuromuscular diseases, critical illness, mechanical ventilation, phrenic nerve, nerve conduction studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Clinical Institute of the Brain, RussiaUniversity, hospital or other
- Collaborators
- City Hospital No 40, Saint Petersburg, Russia
- Study start
- Mar 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 6 May 2009 (estimated)
- 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.
The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.
Detailed description
Since 1984, the problem of critical illness neuromuscular abnormalities (CINMAs) has attracted considerable interest. According to these studies, CINMAs include the muscular weakness that accompanies critical illness resulting from polyneuropathy and/or myopathy and can be seen in 25-85% of cases of critically ill patients. Clinically, CINMAs present as symmetric flaccid tetraparesis and difficulty weaning off mechanical lung ventilation. However, these data are derived from treating non-specialized intensive care unit (ICU) patients. In this research, we wished to investigate CINMAs in neurocritical care patients. From day one of the patients' participation in the research and until a discharge from the ICU (or death), daily neurological surveys and weekly nerve conduction studies were performed. Based on the results of each nerve conduction study, an index of neuromuscular damage was noted to evaluate the severity of the CINMAs. Needle electromyography and muscle biopsy were not used
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from neurosurgical ICU in city clinical hospital
Key inclusion criteria (5 listed)
- Age: 16 years and older
- Acute primary cerebral pathology
- Mechanical ventilation
- Signs of systemic inflammatory response
- Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history
Key exclusion criteria (2 listed)
- Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness
- Inability to perform high-grade nerve conduction studies
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
incidence of critical illness neuromuscular abnormalities (CINMAs)
Time frame: within the first week of mechanical ventilation
3 secondary outcomes
clinical and neurophysiological characteristics of CINMAs
Time frame: within the first week of mechanical ventilation
influence оf phrenic nerve pathology on weaning from mechanical ventilation
Time frame: during weaning period
dynamics of the neurophysiological characteristics of CINMAs
Time frame: during stay in ICU
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 10 Jul 2009.
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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.
Andrey M Alasheev, MD, PhD principal investigator
Clinical Institute of the Brain, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness and Critical Illness, run by Clinical Institute of the Brain, Russia at 1 site in Russia.
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 5 inclusion and 2 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 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
incidence of critical illness neuromuscular abnormalities (CINMAs) (time frame: within the first week of mechanical ventilation). 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 10 Jul 2009.