Epidemiology and Prognosis of Encephalitis in Intensive Care

NCT02906631 | Completed

• 1 other identifier: AOR 15096
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with significant morbidity and mortality. Approximately 50% of patients with AE require ICU admission because of coma, seizures or acute respiratory failure. Determinants of neurological prognosis in these patients are not known. Objectives: Main objective: To identify determinants of outcome in adult patients admitted to the ICU; Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis, EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to describe morbidity and mortality associated with AE at 90 days and 1 year following diagnosis. Methods: prospective observational multicenter study in French ICUs. All patients admitted to the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score \< or =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90 days will be identified by multivariable logistic regression analysis. Duration of study: 30 months (recruitment 18 months, follow-up 12 months). Patients: 300 patients Endpoints:

• Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days following onset of abnormal status (GCS \< or =13). This score will be determined by contacting the patient. A poor outcome will be defined as a mRS \>2 at 90 days.
• Secondary endpoints: a) neurological findings within 7 days following onset of altered mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis) within7 days following onset of altered mental status; c) Time between onset of altered mental status and completion of diagnostic studies; d)Time between onset of altered mental status and start of appropriate specific therapy; e) neurologic outcomes at 1 year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL and SF36 scales;

Conditions

Encephalitis

Keywords

encephalitis,; neurologic outcomes of all-cause encephalitis in intensive care unit; outcome, intensive care unit

Outcome Measures

Primary Outcomes (1)

• Neurological status on the modified Rankin scale

  The primary outcome measure is the modified Rankin scale score 90 days following onset of abnormal status (defined by a GCS score\< or =13). This score will be determined by contacting the patient or his relatives. A poor outcome will be defined as a mRS \>2 at 90 days.

  90 days

Secondary Outcomes (23)

• Biological data within 7 days following onset of altered mental status

  7 days

• State of consciousness defined by the Glasgow Coma Scale within 7 days following onset of altered mental status

  7 days

• Patient's comorbidity measured by Charlson Comorbidity Index

  7 days

• Presence of focal neurological deficit within 7 days following onset of altered mental status

  7 days

• Presence of thermal dysregulation within 7 days following onset of altered mental status

  7 days

Study Arms (1)

patients admitted to the ICU for AE

Adult patients with all-cause encephalitis admitted to an intensive care unit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU for a suspicion of AE (acute encephalopathy and CSF pleocytosis \> 5 cells / microliter) will be eligible for inclusion.

You may qualify if:

• Altered mental status, delirium, or personality changes for a duration \> or = 24 h
• At least 2 of the following: 1) fever (\>38°C) within 72 hours before or following hospital admission; 2) new-onset seizures; 3) new-onset focal signs; 4) CSF pleocytosis \> 5 cell / microl; 5) brain parenchyma abnormalities on neuroimaging compatible with the diagnosis of encephalitis; 6) EEG abnormalities compatible with the diagnosis of encephalitis.
• Altered mental status with a GCS \< or =13 without sedation, or GCS \< or =13 before sedation administration in sedated patients
• CSF analysis performed
• Brain imaging performed (CT/MRI)
• Age \>18

You may not qualify if:

• Time between the first hospitalization for neurologic symptoms in relation with encephalitis and ICU admission \> 21 days
• Purulent bacterial meningitis diagnosed by direct examination or CSF analysis
• Isolated brain abscess.
• Febrile encephalopathy associated with another diagnosis
• Predicted time in ICU \< or = 24 hours

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and cerebrospinal fluid samples

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Romain Sonneville, M.D. Ph.D.

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 20, 2016
• Study Start: October 27, 2017
• Primary Completion: April 20, 2023
• Study Completion: December 1, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

FR (1)