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NCT Number: NCT03470467

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

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Key information

Conditions

Posterior Reversible Encephalopathy Syndrome Brain Diseases Central Nervous System Diseases Hypertensive Encephalopathy Intracranial Hypertension Leukoencephalopathies Nervous System Diseases Posterior Leukoencephalopathy Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit - Versailles Hospital

Le Chesnay, 78150, France

Location status: Recruiting

Location contact

Stephane LEGRIEL, MD

CONTACT

[email protected]

+33139639717

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention planed

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Stephane LEGRIEL, MD

CONTACT

[email protected]

+33139639717

Sponsors and collaborators

Lead sponsor

Ictal Group

Other

Collaborators

  • Versailles Hospital

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2018
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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