Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:54 AM
Study NCT ID:
NCT00893633
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2009-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-09', 'studyFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of critical illness neuromuscular abnormalities (CINMAs)', 'timeFrame': 'within the first week of mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'clinical and neurophysiological characteristics of CINMAs', 'timeFrame': 'within the first week of mechanical ventilation'}, {'measure': 'influence оf phrenic nerve pathology on weaning from mechanical ventilation', 'timeFrame': 'during weaning period'}, {'measure': 'dynamics of the neurophysiological characteristics of CINMAs', 'timeFrame': 'during stay in ICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neuromuscular diseases', 'critical illness', 'mechanical ventilation', 'phrenic nerve', 'nerve conduction studies'], 'conditions': ['Muscle Weakness', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.', 'detailedDescription': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from neurosurgical ICU in city clinical hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 16 years and older\n* Acute primary cerebral pathology\n* Mechanical ventilation\n* Signs of systemic inflammatory response\n* Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history\n\nExclusion Criteria:\n\n* Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness\n* Inability to perform high-grade nerve conduction studies'}, 'identificationModule': {'nctId': 'NCT00893633', 'briefTitle': 'Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Institute of the Brain, Russia'}, 'officialTitle': 'Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit', 'orgStudyIdInfo': {'id': 'CINMAs-2004'}}, 'contactsLocationsModule': {'locations': [{'zip': '620026', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Clinical Institute of the Brain', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Andrey M Alasheev, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Institute of the Brain, Russia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Institute of the Brain, Russia', 'class': 'OTHER'}, 'collaborators': [{'name': 'City Hospital No 40, Saint Petersburg, Russia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Andrey Alasheev', 'oldOrganization': 'Clinical Institute of the Brain, Russia'}}}}