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Recruiting NCT03470467

Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Observational Posterior Reversible Encephalopathy Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Posterior Reversible Encephalopathy Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other No intervention
    No intervention planed

Primary outcome measures

  • Favorable outcome [Time frame: 1 year]
Secondary outcome measures (5)
  • Favorable outcome [Time frame: 3-months and 5-years, 10-years]
  • Functional impairment [Time frame: 3-months and 1-year, 5-years, 10-years]
  • Low or moderate disability [Time frame: 3-months and 1-year, 5-years, 10-years]
  • Recurrent PRES [Time frame: 3-months and 1-year, 5-years, 10-years]
  • Mortality rate [Time frame: ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Intensive Care Unit - Versailles Hospital — Le Chesnay

Identifiers

NCT: NCT03470467 · ICTAL PRES REGISTRY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗