Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

• ClinicalTrials.gov Identifier: NCT03470467
• Recruitment Status: Recruiting
• First Posted: March 20, 2018
• Last Update Posted: August 8, 2019
• Sponsor: Ictal Group
• Collaborator: Versailles Hospital
• Information provided by (Responsible Party): Ictal Group

Study Description

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

Condition or disease	Intervention/treatment
Posterior Reversible Encephalopathy Syndrome	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• Official Title: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
• Actual Study Start Date: March 9, 2018
• Estimated Primary Completion Date: December 31, 2028
• Estimated Study Completion Date: December 31, 2028

Groups and Cohorts

Intervention Details:

• Other: No intervention
  No intervention planed

Outcome Measures

Primary Outcome Measures :

1. Favorable outcome [ Time Frame: 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 :

1. Favorable outcome [ Time Frame: 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]
2. Functional impairment [ Time Frame: 3-months and 1-year, 5-years, 10-years ]
   Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)
3. Low or moderate disability [ Time Frame: 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]

4. Recurrent PRES [ Time Frame: 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)]
5. Mortality rate [ Time Frame: ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years ]
   mortality rate

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients requiring ICU hospitalisation

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

Contacts and Locations

Contacts

Contact: Stephane LEGRIEL, MD; +33139639717; slegriel@ch-versailles.fr

Locations

France

Intensive Care Unit - Versailles Hospital; Recruiting

Le Chesnay, France, 78150

Contact: Stephane LEGRIEL, MD +33139639717 slegriel@ch-versailles.fr

Sponsors and Collaborators

Ictal Group

Versailles Hospital

Investigators

• Principal Investigator: Stephane LEGRIEL, MD; Ictal Group

More Information

Additional Information:

• Responsible Party: Ictal Group
• ClinicalTrials.gov Identifier: NCT03470467
• Other Study ID Numbers: ICTAL PRES REGISTRY
• First Posted: March 20, 2018
• Last Update Posted: August 8, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Brain Diseases; Posterior Leukoencephalopathy Syndrome; Syndrome; Disease; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Hypertensive Encephalopathy; Intracranial Hypertension; Leukoencephalopathies