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Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03470467
Enrollment
300
Registered
2018-03-20
Start date
2018-03-09
Completion date
2028-12-31
Last updated
2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Reversible Encephalopathy Syndrome

Brief summary

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

Interventions

OTHERNo intervention

No intervention planed

Sponsors

Versailles Hospital
CollaboratorOTHER
Ictal Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Favorable outcome1 yearA 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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Secondary

MeasureTime frameDescription
Favorable outcome3-months and 5-years, 10-yearsA 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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Functional impairment3-months and 1-year, 5-years, 10-yearsPercentages of patients with functional impairments (motor, sensitive or cognitive deficits)
Low or moderate disability3-months and 1-year, 5-years, 10-yearsLow 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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Recurrent PRES3-months and 1-year, 5-years, 10-yearspercentages of the patients that experience recurrence of PRES \[defined as a variable combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)\]
Mortality rateICU, hospital discharge, 3-months and 1-year, 5-years, 10-yearsmortality rate

Countries

France

Contacts

Primary ContactStephane LEGRIEL, MD
slegriel@ch-versailles.fr+33139639717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026