Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

NCT03470467 | Recruiting

• 1 other identifier: ICTAL PRES REGISTRY
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Posterior Reversible Encephalopathy Syndrome

Outcome Measures

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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

  1 year

Secondary Outcomes (5)

• Favorable outcome

  3-months and 5-years, 10-years

• Functional impairment

  3-months and 1-year, 5-years, 10-years

• Low or moderate disability

  3-months and 1-year, 5-years, 10-years

• Recurrent PRES

  3-months and 1-year, 5-years, 10-years

• Mortality rate

  ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years

Interventions

No intervention OTHER

No intervention planed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients requiring ICU hospitalisation

You may qualify if:

• 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

You may not qualify if:

• normal cerebral imaging

Sponsors & Collaborators

• Ictal Group: lead
• Versailles Hospital: collaborator

Study Sites (1)

Intensive Care Unit - Versailles Hospital

Le Chesnay, 78150, France

RECRUITING

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies

Study Officials

• Stephane LEGRIEL, MD

  Ictal Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephane LEGRIEL, MD

CONTACT

+33139639717; slegriel@ch-versailles.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 20, 2018
• Study Start: March 9, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 8, 2019

Record last verified: 2019-07

Locations

FR (1)