EURopean Study on Encephalitis in Intensive CAre

NCT ID: NCT03144570

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

596 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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)

Conditions

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Encephalitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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None, non-interventional study

Not applicable, non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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 ... )
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ICUREsearch

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean François Timsit

Role: STUDY_CHAIR

ICUREsearch

Romain Sonneville

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat, APHP

Locations

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Medical University of Innsbruck

Innsbruck, , Austria

Site Status

Centre Hospitalier d'Angoulême

Angoulême, , France

Site Status

Centre Hospitalier Annecy Genevois

Annecy, , France

Site Status

Hôpital Victor Dupouy

Argenteuil, , France

Site Status

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status

CHU Brest

Brest, , France

Site Status

Hôpital Pierre Wertheimer

Bron, , France

Site Status

Centre Hospitalier René Dubos

Cergy-Pontoise, , France

Site Status

CH de Charlesville-Mézières

Charleville-Mézières, , France

Site Status

Les Hôpitaux de Chartres

Chartres, , France

Site Status

Centre Hospitalier Châlons en Champagne

Châlons-en-Champagne, , France

Site Status

Centre Hospitalier Public du Cotentin

Cherbourg, , France

Site Status

Hôpital Antoine Béclère

Clamart, , France

Site Status

CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

APHP Colombes - Louis Mourier

Colombes, , France

Site Status

Centre Hospitalier du Sud Francilien

Corbeil-Essonnes, , France

Site Status

Hôpitaux Universitaires Henri Mondor

Créteil, , France

Site Status

Centre hopsitalier de Dieppe

Dieppe, , France

Site Status

Centre hospitalier Sud Essone

Étampes, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

Marne la Vallée - Meaux

Jossigny, , France

Site Status

CH Vendée

La Roche, , France

Site Status

CH du Mans

Le Mans, , France

Site Status

Hôpital R Salengro

Lille, , France

Site Status

Centre Hospitalier Lorient

Lorient, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Institut Paoli-Calmettes

Marseille, , France

Site Status

Hôpital de la Timone

Marseille, , France

Site Status

CHU Hôpital Nord

Marseille, , France

Site Status

CHR Metz-Thionville

Metz, , France

Site Status

CHU Lapeyronie

Montpellier, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Hôpital de la Source

Orléans, , France

Site Status

Hôpital Saint Louis

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Hôpital Européen Georges-Pompidou

Paris, , France

Site Status

Hôpital Bichat Claude Bernard

Paris, , France

Site Status

Hôpitaux universitaires Est Parisien, Tenon

Paris, , France

Site Status

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status

Groupe hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

Fondation Opthalmologique Adolphe de Rothschild

Paris, , France

Site Status

Centre Hospitalier de Pau

Pau, , France

Site Status

Centre Hospitalier Intercommunal de Poissy

Poissy, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CH Roanne

Roanne, , France

Site Status

Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

Saint-Denis, , France

Site Status

CHU de Toulouse Purpan

Toulouse, , France

Site Status

Centre hospitalier de Tourcoing

Tourcoing, , France

Site Status

Hôpital André Mignot

Versailles, , France

Site Status

CH des 2 vallées, Site Longjumeau

Longjumeau, Île-de-France Region, France

Site Status

Ims & Sum Hospital

Bhubaneswar, , India

Site Status

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, , India

Site Status

Institute Of Medical Sciences Banaras Hindu University

Lucknow, , India

Site Status

King George's medical university

Lucknow, , India

Site Status

Sri Ramachandra Institute of Higher Education and Research

Lucknow, , India

Site Status

Azienda USL Toscana Centro

Florence, , Italy

Site Status

San Gerardo Hospital

Monza, , Italy

Site Status

Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital de la Santa Creu

Barcelona, , Spain

Site Status

Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status

Hospital Universitari Arnau de Vilanova

Zaragoza, , Spain

Site Status

Countries

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Austria France India Italy Netherlands Spain

References

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Sonneville R, de Montmollin E, Contou D, Ferrer R, Gurjar M, Klouche K, Sarton B, Demeret S, Bailly P, da Silva D, Escudier E, Le Guennec L, Chabanne R, Argaud L, Ben Hadj Salem O, Thyrault M, Frerou A, Louis G, De Pascale G, Horn J, Helbok R, Geri G, Bruneel F, Martin-Loeches I, Taccone FS, De Waele JJ, Ruckly S, Staiquly Q, Citerio G, Timsit JF; EURECA Investigator Study Group. Clinical features, etiologies, and outcomes in adult patients with meningoencephalitis requiring intensive care (EURECA): an international prospective multicenter cohort study. Intensive Care Med. 2023 May;49(5):517-529. doi: 10.1007/s00134-023-07032-9. Epub 2023 Apr 6.

Reference Type DERIVED
PMID: 37022378 (View on PubMed)

Other Identifiers

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0008

Identifier Type: -

Identifier Source: org_study_id

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