An observational study in Posterior Reversible Encephalopathy Syndrome, sponsored by Ictal Group. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by Ictal Group · Observational
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
Ictal Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
critically ill patients requiring ICU hospitalisation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Posterior Reversible Encephalopathy Syndrome defined as:
Exclusion Criteria:
No intervention planed
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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Time frame: 1 year
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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Time frame: 3-months and 5-years, 10-years
Functional impairment
Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)
Time frame: 3-months and 1-year, 5-years, 10-years
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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Time frame: 3-months and 1-year, 5-years, 10-years
Recurrent PRES
percentages of the patients that experience recurrence of PRES \[defined as a variable combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)\]
Time frame: 3-months and 1-year, 5-years, 10-years
Mortality rate
mortality rate
Time frame: ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years
Plan to share: Undecided
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