EURopean Study on Encephalitis in Intensive CAre

Encephalitis Clinical Trial

— EURECA  

Official title:

EURopean Study on Encephalitis in Intensive CAre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144570
• Other study ID #: 0008
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: ICUREsearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 31, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ... )

Related Conditions & MeSH terms

• Encephalitis

Intervention

Other:
• None, non-interventional study
Not applicable, non-interventional study

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
France	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	Centre Hospitalier Châlons en Champagne	Châlons-en-Champagne
France	CH de Charlesville-Mézières	Charleville-Mézières
France	Les Hôpitaux de Chartres	Chartres
France	Centre Hospitalier Public du Cotentin	Cherbourg
France	Hôpital Antoine Béclère	Clamart
France	CHU Gabriel Montpied	Clermont-Ferrand
France	APHP Colombes - Louis Mourier	Colombes
France	Centre Hospitalier du Sud Francilien	Corbeil-Essonnes
France	Hôpitaux Universitaires Henri Mondor	Créteil
France	Centre hopsitalier de Dieppe	Dieppe
France	Centre hospitalier Sud Essone	Étampes
France	CHU Grenoble	Grenoble
France	Marne la Vallée - Meaux	Jossigny
France	CH Vendée	La Roche
France	CH du Mans	Le Mans
France	Hôpital R Salengro	Lille
France	CH des 2 vallées, Site Longjumeau	Longjumeau	Île De France
France	Centre Hospitalier Lorient	Lorient
France	Hôpital Edouard Herriot	Lyon
France	CHU Hôpital Nord	Marseille
France	Hôpital de la Timone	Marseille
France	Institut Paoli-Calmettes	Marseille
France	CHR Metz-Thionville	Metz
France	CHU Lapeyronie	Montpellier
France	CHU de Nantes	Nantes
France	Hôpital de la Source	Orléans
France	Fondation Opthalmologique Adolphe de Rothschild	Paris
France	Groupe Hospitalier Paris Saint-Joseph	Paris
France	Groupe hospitalier Pitié-Salpêtrière	Paris
France	Hôpital Bichat Claude Bernard	Paris
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges-Pompidou	Paris
France	Hôpital Saint Louis	Paris
France	Hôpitaux universitaires Est Parisien, Tenon	Paris
France	Centre Hospitalier de Pau	Pau
France	Centre Hospitalier Intercommunal de Poissy	Poissy
France	CHU Rennes	Rennes
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
India	Ims & Sum Hospital	Bhubaneswar
India	Institute Of Medical Sciences Banaras Hindu University	Lucknow
India	King George's medical university	Lucknow
India	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow
India	Sri Ramachandra Institute of Higher Education and Research	Lucknow
Italy	Azienda USL Toscana Centro	Firenze
Italy	San Gerardo Hospital	Monza
Italy	Università Cattolica del Sacro Cuore	Roma
Netherlands	Academic Medical Center	Amsterdam
Spain	Germans Trias i Pujol	Barcelona
Spain	Hospital de la Santa Creu	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Universitari Arnau de Vilanova	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
ICUREsearch

Countries where clinical trial is conducted

Austria,  France,  India,  Italy,  Netherlands,  Spain, 

Outcome

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