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Completed

NCT Number: NCT03144570

EURopean Study on Encephalitis in Intensive CAre

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Innsbruck, Austria

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ... )

Treatment and study plan

None, non-interventional study

Other

Not applicable, non-interventional study

Primary outcomes

  1. Modified Rankin scale score

    Time frame: 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 outcomes

  1. Mortality at Day 28

    Time frame: Day 28

    Rate of death at day 28

  2. Systematic complications

    Time frame: Day 90

    Septic shock, hyponatremia

  3. Intracranial complications

    Time frame: Day 90

    Documented seizures, status epilepticus, Diffuse cerebral edema, herniation, Ischemia, cerebral hemorrhage

  4. Intracranial pressure monitoring

    Time frame: Day 90

    List of all available methods of intracranial pressure monitoring used in study sites and their outcome

  5. Neurosurgery

    Time frame: Day 90

    Monitoring of neurosurgery to identify additional prognosis factors

Sponsors and collaborators

Lead sponsor

ICUREsearch

Industry

Registry information

Acronym: EURECA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 9, 2017
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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