EURopean Study on Encephalitis in Intensive CAre

Completed

• Conditions: Encephalitis

• Registration Number: NCT03144570
• Lead Sponsor: ICUREsearch

Brief Summary

Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

Detailed Description

Primary objective :

evaluate the correlation between mRs score and the baseline characteristics Functional outcomes will be evaluated using the modified Rankin score (mRS) score, which is one of the most frequently used scores in acute neurological diseases \[18\]. A poor outcome will be defined by a mRS score \> 2 (functional dependence or death). The investigator usually evaluates this score if the patient is still in the hospital 90 days after admission. Patients discharged from hospital within 90 days following ICU admission without major disability (mRS 0, 1 or 2) are considered to have a good outcome. Patients discharged within 90 days with a disability will be classified for the study according to the latest available data. Patients will not be contacted directly by the investigator for the study purposes.

Secondary objectives :

To identify additional prognosis factors : the clinical, radiological, biological and neurophysiological factors associated with poor outcome for patients admitted to the ICU with AE

* Day 28 mortality, in-ICU mortality, in-hospital mortality

* Major systemic complications (septic shock, hyponatremia, nosocomial pneumonia, catheter-related BSI, overt gastroenteral bleeding, pulmonary embolism)

* Major intracranial complications during ICU stay

* Status epilepticus

* Brain death

* Empyema/cerebral abscess

* Cerebral ischemia

* Intracranial bleeding

* ICP monitoring

* Neurosurgery

The cause of death will be categorized into 2 categories:

* Systemic causes (cardiovascular failure, MOF)

* Neurological cause (Diffuse neurologic injury or withdrawal of care)

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Study Start: 2017-06-01
• Primary Completion: 2020-07-06
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

• Age ≥ 18 years

• non-opposition to participate in the study (or consent if applicable according to local legislation)

• Impaired consciousness (altered mentation, stupor, or personality changes) for a duration ≥ 24 h, without obvious explanation

• A score on the Glasgow Coma Scale < or =13 at ICU admission

• A Cerebrospinal fluid pleocytosis > = 5 cell / mm3

• At least 2 of the following :

  • Fever (≥ 38.0 °C) within 72 hours before or after admission
  • Generalized or partial seizures non-attributable to pre-existing epilepsy
  • New onset focal neurological deficit
  • Parenchymal abnormalities on MRI compatible with AE
  • EEG alterations compatible with AE.

Exclusion Criteria

• CSF or neuroimaging not available (s) or not performed.
• febrile encephalopathy associated with another diagnosis (sepsis, neurological disease with aspiration pneumonia ... )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale score	Day 90	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.

Secondary Outcome Measures

Name	Time	Method
Intracranial complications	Day 90	Documented seizures, status epilepticus, Diffuse cerebral edema, herniation, Ischemia, cerebral hemorrhage
Mortality at Day 28	Day 28	Rate of death at day 28
Systematic complications	Day 90	Septic shock, hyponatremia
Intracranial pressure monitoring	Day 90	List of all available methods of intracranial pressure monitoring used in study sites and their outcome
Neurosurgery	Day 90	Monitoring of neurosurgery to identify additional prognosis factors

Trial Locations

Locations (65)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

Centre Hospitalier d'Angoulême; 🇫🇷 Angoulême, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Annecy, France

Hôpital Victor Dupouy; 🇫🇷 Argenteuil, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CHU Brest; 🇫🇷 Brest, France

Hôpital Pierre Wertheimer; 🇫🇷 Bron, France

Centre Hospitalier René Dubos; 🇫🇷 Cergy-Pontoise, France

CH de Charlesville-Mézières; 🇫🇷 Charleville-Mézières, France

Les Hôpitaux de Chartres; 🇫🇷 Chartres, France

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