Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03470467
Status:
RECRUITING
Last Update Posted:
2019-08-08
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054038', 'term': 'Posterior Leukoencephalopathy Syndrome'}], 'ancestors': [{'id': 'D020343', 'term': 'Hypertensive Encephalopathy'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Favorable outcome', 'timeFrame': '1 year', 'description': 'A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined during a structured interview conducted by an independent assessor. The GOS score : \\[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\\]'}], 'secondaryOutcomes': [{'measure': 'Favorable outcome', 'timeFrame': '3-months and 5-years, 10-years', 'description': 'A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined during a structured interview conducted by an independent assessor. The GOS score : \\[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\\]'}, {'measure': 'Functional impairment', 'timeFrame': '3-months and 1-year, 5-years, 10-years', 'description': 'Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)'}, {'measure': 'Low or moderate disability', 'timeFrame': '3-months and 1-year, 5-years, 10-years', 'description': 'Low or moderate disability is defined by a Glasgow Outcome Scale (GOS) of 4 or 5.\n\nThe Glasgow Outcome Scale (GOS) will be determined during a structured interview conducted by an independent assessor. The GOS score : \\[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\\]'}, {'measure': 'Recurrent PRES', 'timeFrame': '3-months and 1-year, 5-years, 10-years', 'description': 'percentages of the patients that experience recurrence of PRES \\[defined as a variable combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)\\]'}, {'measure': 'Mortality rate', 'timeFrame': 'ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years', 'description': 'mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posterior Reversible Encephalopathy Syndrome']}, 'descriptionModule': {'briefSummary': 'Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill patients requiring ICU hospitalisation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years\n* Posterior Reversible Encephalopathy Syndrome defined as:\n\n * combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND\n * cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)\n* intensive care unit admission\n\nExclusion Criteria:\n\n* normal cerebral imaging'}, 'identificationModule': {'nctId': 'NCT03470467', 'briefTitle': 'Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ictal Group'}, 'officialTitle': 'Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients', 'orgStudyIdInfo': {'id': 'ICTAL PRES REGISTRY'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention planed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78150', 'city': 'Le Chesnay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephane LEGRIEL, MD', 'role': 'CONTACT', 'email': 'slegriel@ch-versailles.fr', 'phone': '+33139639717'}], 'facility': 'Intensive Care Unit - Versailles Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}], 'centralContacts': [{'name': 'Stephane LEGRIEL, MD', 'role': 'CONTACT', 'email': 'slegriel@ch-versailles.fr', 'phone': '+33139639717'}], 'overallOfficials': [{'name': 'Stephane LEGRIEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ictal Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ictal Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Versailles Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}