EURopean Study on Encephalitis in Intensive CAre (EURECA)

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis
• Intervention / Treatment: Other: None, non-interventional study

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 Type: Observational
• Enrollment (Actual): 596

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Medical University of Innsbruck
• France
  • Angoulême, France, 16000
    • Centre Hospitalier d'Angoulème
  • Annecy, France, 74370
    • Centre Hospitalier Annecy Genevois
  • Argenteuil, France, 95107
    • Hôpital Victor Dupouy
  • Boulogne-Billancourt, France, 92104
    • Hôpital Ambroise Paré
  • Brest, France, 29200
    • CHU Brest
  • Bron, France, 69677
    • Hôpital Pierre Wertheimer
  • Cergy-Pontoise, France, 95303
    • Centre Hospitalier René Dubos
  • Charleville-Mézières, France, 08011
    • CH de Charlesville-Mézières
  • Chartres, France, 28018
    • Les Hôpitaux de Chartres
  • Cherbourg, France, 50100
    • Centre Hospitalier Public du Cotentin
  • Châlons-en-Champagne, France, 51000
    • Centre Hospitalier Châlons en Champagne
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
  • Clermont-Ferrand, France, 63000
    • Chu Gabriel Montpied
  • Colombes, France, 92701
    • APHP Colombes - Louis Mourier
  • Corbeil-Essonnes, France, 91160
    • Centre Hospitalier du Sud Francilien
  • Créteil, France, 94000
    • Hôpitaux Universitaires Henri Mondor
  • Dieppe, France, 76200
    • Centre hopsitalier de Dieppe
  • Grenoble, France, 38043
    • CHU Grenoble
  • Jossigny, France, 77600
    • Marne la Vallée - Meaux
  • La Roche, France, 85925
    • CH Vendée
  • Le Mans, France, 72037
    • CH du Mans
  • Lille, France, 59000
    • Hôpital R Salengro
  • Lorient, France, 56322
    • Centre Hospitalier Lorient
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13009
    • Institut Paoli-Calmettes
  • Marseille, France, 13385
    • Hopital de la Timone
  • Marseille, France, 13915
    • CHU Hopital Nord
  • Metz, France, 57085
    • CHR Metz-Thionville
  • Montpellier, France, 34090
    • CHU Lapeyronie
  • Nantes, France, 44093
    • CHU de Nantes
  • Orléans, France, 45100
    • Hôpital de la Source
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Paris, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris, France, 75020
    • Hôpitaux universitaires Est Parisien, Tenon
  • Paris, France, 75104
    • Groupe Hospitalier Paris Saint-Joseph
  • Paris, France, 75940
    • Fondation Opthalmologique Adolphe de Rothschild
  • Pau, France, 64000
    • Centre Hospitalier de Pau
  • Poissy, France, 78303
    • Centre Hospitalier Intercommunal de Poissy
  • Rennes, France, 35033
    • Chu Rennes
  • Roanne, France
    • CH Roanne
  • Saint-Denis, France, 93200
    • Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE
  • Toulouse, France, 31300
    • CHU de Toulouse Purpan
  • Tourcoing, France, 59200
    • Centre Hospitalier de Tourcoing
  • Versailles, France, 78150
    • Hopital Andre Mignot
  • Étampes, France, 91150
    • Centre hospitalier Sud Essone
  • Île De France
    • Longjumeau, Île De France, France, 91160
      • CH des 2 vallées, Site Longjumeau
• India
  • Bhubaneswar, India
    • IMS & SUM Hospital
  • Lucknow, India, 226014
    • Sanjay Gandhi Post Graduate Institute of Medical Sciences
  • Lucknow, India
    • King George's Medical University
  • Lucknow, India
    • Institute Of Medical Sciences Banaras Hindu University
  • Lucknow, India
    • Sri Ramachandra Institute of Higher Education and Research
• Italy
  • Firenze, Italy
    • Azienda USL Toscana Centro
  • Monza, Italy, 20900
    • San Gerardo Hospital
  • Roma, Italy, 00168
    • Universita Cattolica del Sacro Cuore
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Academic Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08916
    • Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense
  • Zaragoza, Spain
    • Hospital Universitari Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin scale score	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.	Day 90

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ICUREsearch
• Investigators: Study Chair: Jean François Timsit, ICUREsearch; Principal Investigator: Romain Sonneville, Hopital Bichat, APHP

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ICU, encephalitis, meningo-encephalitis, seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis
• Other Study ID Numbers: 0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No