Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIctal Group
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age >= 18 years
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
Disqualifiers
normal cerebral imaging
Trial population
critically ill patients requiring ICU hospitalisation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention planed
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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-years2
Functional impairment
Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)
Time frame
3-months and 1-year, 5-years, 10-years3
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-years4
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-yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ictal Group
Lead sponsor
Versailles Hospital
Collaborator
Source ClinicalTrials.gov