Clinical trial NCT03144570: EURopean Study on Encephalitis in Intensive CAre
Official title: EURopean Study on Encephalitis in Intensive CAre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalitis
Keywords: ICU, encephalitis, meningo-encephalitis, seizures
Lead sponsor: ICUREsearch
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 patients admitted to the ICU for AE (5 consecutive patients in each participating ICU, targeted number of ICUs in Europe : 200).

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)

Eligibility criteria: 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 ... )

Primary outcomes:
measure: Modified Rankin scale score
timeFrame: Day 90
Secondary outcomes:
measure: Mortality at Day 28
timeFrame: Day 28
measure: Systematic complications
timeFrame: Day 90
measure: Intracranial complications
timeFrame: Day 90
measure: Intracranial pressure monitoring
timeFrame: Day 90
measure: Neurosurgery
timeFrame: Day 90
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Angoulême
country: France
facility: Centre Hospitalier d'Angoulême
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Argenteuil
country: France
facility: Hôpital Victor Dupouy
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: CHU Brest
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Cergy-Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Charleville-Mézières
country: France
facility: CH de Charlesville-Mézières
city: Chartres
country: France
facility: Les Hôpitaux de Chartres
city: Cherbourg
country: France
facility: Centre Hospitalier Public du Cotentin
city: Châlons-en-Champagne
country: France
facility: Centre Hospitalier Châlons en Champagne
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Colombes
country: France
facility: APHP Colombes - Louis Mourier
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier du Sud Francilien
city: Créteil
country: France
facility: Hôpitaux Universitaires Henri Mondor
city: Dieppe
country: France
facility: Centre hopsitalier de Dieppe
city: Grenoble
country: France
facility: CHU Grenoble
city: Jossigny
country: France
facility: Marne la Vallée - Meaux
city: La Roche
country: France
facility: CH Vendée
city: Le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: Hôpital R Salengro
city: Lorient
country: France
facility: Centre Hospitalier Lorient
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: Hôpital de la Timone
city: Marseille
country: France
facility: CHU Hôpital Nord
city: Metz
country: France
facility: CHR Metz-Thionville
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Nantes
country: France
facility: CHU de Nantes
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Hôpitaux universitaires Est Parisien, Tenon
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Paris
country: France
facility: Groupe hospitalier Pitié-Salpêtrière
city: Paris
country: France
facility: Fondation Opthalmologique Adolphe de Rothschild
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal de Poissy
city: Rennes
country: France
facility: CHU Rennes
city: Roanne
country: France
facility: CH Roanne
city: Saint-Denis
country: France
facility: Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE
city: Toulouse
country: France
facility: CHU de Toulouse Purpan
city: Tourcoing
country: France
facility: Centre hospitalier de Tourcoing
city: Versailles
country: France
facility: Hôpital André Mignot
city: Étampes
country: France
facility: Centre hospitalier Sud Essone
city: Longjumeau
country: France
facility: CH des 2 vallées, Site Longjumeau
state: Île De France
city: Bhubaneswar
country: India
facility: Ims & Sum Hospital
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences
city: Lucknow
country: India
facility: Institute Of Medical Sciences Banaras Hindu University
city: Lucknow
country: India
facility: King George's medical university
city: Lucknow
country: India
facility: Sri Ramachandra Institute of Higher Education and Research
city: Firenze
country: Italy
facility: Azienda USL Toscana Centro
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu
city: Barcelona
country: Spain
facility: Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Zaragoza
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
affiliation: ICUREsearch
name: Jean François Timsit
role: STUDY_CHAIR
affiliation: Hôpital Bichat, APHP
name: Romain Sonneville
role: PRINCIPAL_INVESTIGATOR
References: