EURopean Study on Encephalitis in Intensive CAre
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 596
-
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.
- 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
CHU Brest
🇫🇷Brest, France
Centre hopsitalier de Dieppe
🇫🇷Dieppe, France
Hôpital Victor Dupouy
🇫🇷Argenteuil, France
Les Hôpitaux de Chartres
🇫🇷Chartres, France
Centre Hospitalier du Sud Francilien
🇫🇷Corbeil-Essonnes, France
Centre Hospitalier René Dubos
🇫🇷Cergy-Pontoise, France
CH de Charlesville-Mézières
🇫🇷Charleville-Mézières, France
CH Vendée
🇫🇷La Roche, France
Hôpital de la Source
🇫🇷Orléans, France
Hôpital Saint Louis
🇫🇷Paris, France
Hôpital Européen Georges-Pompidou
🇫🇷Paris, France
Centre Hospitalier Public du Cotentin
🇫🇷Cherbourg, France
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Centre Hospitalier Lorient
🇫🇷Lorient, France
CHU Lapeyronie
🇫🇷Montpellier, France
Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
San Gerardo Hospital
🇮🇹Monza, Italy
Hôpitaux Universitaires Henri Mondor
🇫🇷Créteil, France
Hôpital Cochin
🇫🇷Paris, France
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
APHP Colombes - Louis Mourier
🇫🇷Colombes, France
CHU Grenoble
🇫🇷Grenoble, France
CH du Mans
🇫🇷Le Mans, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Hôpital de la Timone
🇫🇷Marseille, France
CHU Hôpital Nord
🇫🇷Marseille, France
CHR Metz-Thionville
🇫🇷Metz, France
CHU de Nantes
🇫🇷Nantes, France
Groupe Hospitalier Paris Saint-Joseph
🇫🇷Paris, France
Groupe hospitalier Pitié-Salpêtrière
🇫🇷Paris, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Centre Hospitalier Annecy Genevois
🇫🇷Annecy, France
Hôpital Pierre Wertheimer
🇫🇷Bron, France
Hôpital Antoine Béclère
🇫🇷Clamart, France
Centre Hospitalier Châlons en Champagne
🇫🇷Châlons-en-Champagne, France
Marne la Vallée - Meaux
🇫🇷Jossigny, France
Hôpital R Salengro
🇫🇷Lille, France
Hôpital Bichat Claude Bernard
🇫🇷Paris, France
Hôpitaux universitaires Est Parisien, Tenon
🇫🇷Paris, France
Fondation Opthalmologique Adolphe de Rothschild
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
Centre Hospitalier Intercommunal de Poissy
🇫🇷Poissy, France
CH Roanne
🇫🇷Roanne, France
Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE
🇫🇷Saint-Denis, France
CHU de Toulouse Purpan
🇫🇷Toulouse, France
Centre hospitalier de Tourcoing
🇫🇷Tourcoing, France
Hôpital André Mignot
🇫🇷Versailles, France
Centre hospitalier Sud Essone
🇫🇷Étampes, France
CH des 2 vallées, Site Longjumeau
🇫🇷Longjumeau, Île De France, France
Ims & Sum Hospital
🇮🇳Bhubaneswar, India
Institute Of Medical Sciences Banaras Hindu University
🇮🇳Lucknow, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, India
King George's medical university
🇮🇳Lucknow, India
Sri Ramachandra Institute of Higher Education and Research
🇮🇳Lucknow, India
Azienda USL Toscana Centro
🇮🇹Firenze, Italy
Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu
🇪🇸Barcelona, Spain
Germans Trias i Pujol
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario de Ourense
🇪🇸Ourense, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Zaragoza, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain