Posterior Reversible Encephalopathy Syndrome Clinical Trial
Official title:
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
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
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age >= 18 years - Posterior Reversible Encephalopathy Syndrome defined as: - 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) - intensive care unit admission Exclusion Criteria: - normal cerebral imaging |
Country | Name | City | State |
---|---|---|---|
France | Intensive Care Unit - Versailles Hospital | Le Chesnay |
Lead Sponsor | Collaborator |
---|---|
Ictal Group | Versailles Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Favorable outcome | 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] | 1 year | |
Secondary | Favorable outcome | 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] | 3-months and 5-years, 10-years | |
Secondary | Functional impairment | Percentages of patients with functional impairments (motor, sensitive or cognitive deficits) | 3-months and 1-year, 5-years, 10-years | |
Secondary | Low or moderate disability | Low or moderate disability is defined by a Glasgow Outcome Scale (GOS) of 4 or 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] |
3-months and 1-year, 5-years, 10-years | |
Secondary | Recurrent PRES | 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)] | 3-months and 1-year, 5-years, 10-years | |
Secondary | Mortality rate | mortality rate | ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years |
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