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Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02003196
Collaborator
(none)
375
Enrollment
1
Location
74.6
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    PCR for herpes simplex virus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results PCR for Cytomegalovirus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    375 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)
    Actual Study Start Date :
    Jan 5, 2014
    Actual Primary Completion Date :
    Mar 26, 2020
    Actual Study Completion Date :
    Mar 26, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Ventilatory-free days at day 90 [90 days]

    Secondary Outcome Measures

    1. Bacterial hospital acquiered infection [28 days]

    2. organ failure [28 days]

    3. hospitalisation length of stay [28 days]

    4. Mortality [28 days and 90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hospitalisation in intensive care unit

    • Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale <= 12

    • Age between 18 and 75 years

    • Mechanical ventilation > 24 hours

    Exclusion Criteria:

    • encephalopathy post anoxy

    • active cancer

    • Immunosuppresseur treatment

    • pregnancy

    • history of autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nantes Nantes France

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Karim Asehnoune, Pr, CHU de Nantes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT02003196
    Other Study ID Numbers:
    • RC13_0228
    First Posted:
    Dec 6, 2013
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Nantes University Hospital
    Brain injury
    virus
    immunosuppression
    mechanical ventilation
    Additional relevant MeSH terms:
    Brain Injuries

    Study Results

    No Results Posted as of Aug 25, 2021