Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Recruiting

• Conditions: Posterior Reversible Encephalopathy Syndrome

• Registration Number: NCT03470467
• Lead Sponsor: Ictal Group

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-09
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Favorable outcome	1 year	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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intensive Care Unit - Versailles Hospital; 🇫🇷 Le Chesnay, France