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Completed

NCT Number: NCT02003196

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Infections Nervous System Diseases Trauma, Nervous System Virus Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Ventilatory-free days at day 90

    Time frame: 90 days

Secondary outcomes

  1. Bacterial hospital acquiered infection

    Time frame: 28 days

  2. organ failure

    Time frame: 28 days

  3. hospitalisation length of stay

    Time frame: 28 days

  4. Mortality

    Time frame: 28 days and 90 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: IBIS-VIRUS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2013
Registry last updated
Aug 25, 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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