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EURopean Study on Encephalitis in Intensive CAre

EURopean Study on Encephalitis in Intensive CAre

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03144570
Acronym
EURECA
Enrollment
596
Registered
2017-05-09
Start date
2017-06-01
Completion date
2020-12-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalitis

Keywords

ICU, encephalitis, meningo-encephalitis, seizures

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)

Interventions

Not applicable, non-interventional study

Sponsors

ICUREsearch
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 ... )

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin scale scoreDay 90The 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

MeasureTime frameDescription
Mortality at Day 28Day 28Rate of death at day 28
Systematic complicationsDay 90Septic shock, hyponatremia
Intracranial complicationsDay 90Documented seizures, status epilepticus, Diffuse cerebral edema, herniation, Ischemia, cerebral hemorrhage
Intracranial pressure monitoringDay 90List of all available methods of intracranial pressure monitoring used in study sites and their outcome
NeurosurgeryDay 90Monitoring of neurosurgery to identify additional prognosis factors

Countries

Austria, France, India, Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026