Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Posterior Reversible Encephalopathy Syndrome Clinical Trial

Official title:

Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03470467
• Other study ID #: ICTAL PRES REGISTRY
• Status: Recruiting
• Start date: March 9, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2019
• Source: Ictal Group
• Contact: Stephane LEGRIEL, MD
• Phone: +33139639717
• Email: slegriel[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Critical Illness
• Posterior Reversible Encephalopathy Syndrome
• Syndrome

Intervention

Other:
• No intervention
No intervention planed

Locations

Country	Name	City	State
France	Intensive Care Unit - Versailles Hospital	Le Chesnay

Sponsors (2)

Lead Sponsor	Collaborator
Ictal Group	Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Functional impairment	Percentages of patients with functional impairments (motor, sensitive or cognitive deficits)	3-months and 1-year, 5-years, 10-years
Secondary	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
Secondary	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
Secondary	Mortality rate	mortality rate	ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years