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

This study is currently recruiting participants.
Verified March 2016 by Nantes University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02003196
First Posted: December 6, 2013
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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
Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Ventilatory-free days at day 90 [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • Bacterial hospital acquiered infection [ Time Frame: 28 days ]
  • organ failure [ Time Frame: 28 days ]
  • hospitalisation length of stay [ Time Frame: 28 days ]
  • Mortality [ Time Frame: 28 days and 90 days ]

Estimated Enrollment: 500
Study Start Date: February 2014
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale <= 12
  • Age between 18 and 75 years
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003196


Contacts
Contact: Asehnoune Karim karim.asehnoune@chu-nantes.fr

Locations
France
CHU de Nantes Recruiting
Nantes, France
Contact: Karim Asehnoune, Pr       karim.asehnoune@chu-nantes.fr   
Contact: Delphine Flattres Duchaussoy       delphine.flattresduchaussoy@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Karim Asehnoune, Pr CHU de Nantes
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02003196     History of Changes
Other Study ID Numbers: RC13_0228
First Submitted: December 2, 2013
First Posted: December 6, 2013
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Nantes University Hospital:
Brain injury
virus
immunosuppression
mechanical ventilation

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries