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

Brain Injury Clinical Trial

— IBIS-VIRUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003196
• Other study ID #: RC13_0228
• Status: Completed
• Start date: January 5, 2014
• Est. completion date: March 26, 2020

Study information

• Verified date: August 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory-free days at day 90		90 days
Secondary	Bacterial hospital acquiered infection		28 days
Secondary	organ failure		28 days
Secondary	hospitalisation length of stay		28 days
Secondary	Mortality		28 days and 90 days