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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02003196
First received: December 2, 2013
Last updated: March 22, 2016
Last verified: March 2016

December 2, 2013
March 22, 2016
February 2014
February 2019   (final data collection date for primary outcome measure)
Ventilatory-free days at day 90 [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Ventilatory-free days at day 90 [ Time Frame: 90 days ]
Complete list of historical versions of study NCT02003196 on ClinicalTrials.gov Archive Site
  • Bacterial hospital acquiered infection [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • organ failure [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • hospitalisation length of stay [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 28 days and 90 days ] [ Designated as safety issue: Yes ]
  • 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 ]
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Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)
Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)
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.
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
  • Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale <= 12
  • Age between 18 and 75 years
Brain Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
February 2019   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact: Asehnoune Karim karim.asehnoune@chu-nantes.fr
France
 
NCT02003196
RC13_0228
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Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Karim Asehnoune, Pr CHU de Nantes
Nantes University Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP