Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

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

Study Overview

• Status: Recruiting
• Conditions: Posterior Reversible Encephalopathy Syndrome
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Recruiting
    • Intensive Care Unit - Versailles Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

critically ill patients requiring ICU hospitalisation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	3-months and 5-years, 10-years
Functional impairment	Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)	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]	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)]	3-months and 1-year, 5-years, 10-years
Mortality rate	mortality rate	ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years

Collaborators and Investigators

• Sponsor: Ictal Group
• Collaborators: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Leukoencephalopathies; Hypertensive Encephalopathy; Intracranial Hypertension; Syndrome; Brain Diseases; Posterior Leukoencephalopathy Syndrome
• Other Study ID Numbers: ICTAL PRES REGISTRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No