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Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study (CMV-Réa)

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ClinicalTrials.gov Identifier: NCT02843880
Recruitment Status : Terminated (Problematic has become outdated in relation with current litterature advances.)
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble

Brief Summary:

Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms.

In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.


Condition or disease
CMV Infection

Detailed Description:

Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.

A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.


Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Septic shock patients
Septic shock patients staying over 3 days mechanically ventilated in the ICU



Primary Outcome Measures :
  1. Occurrence of CMV disease [ Time Frame: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks) ]
    CMV disease is defined by occurence of viremia and/or an organ failure


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Day 28 ]
  2. Length of ICU stay [ Time Frame: About 90 days ]
  3. Duration of mechanical ventilation [ Time Frame: About 90 days ]
  4. Occurence of nosocomial infections [ Time Frame: About 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted in ICU for septic shock, without previous immunodepression, and who will stay in ICU for over 3 days, mechanically ventialted
Criteria

Inclusion Criteria:

  • 18 years or older
  • ICU admission for more than 3 days
  • Admission for septic shock
  • Patient with mechanical invasive ventilation

Exclusion Criteria:

  • Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
  • Seronegative patient for CMV
  • Patient under anti-virus treatment
  • Patient under guardianship

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): NCT02843880


Locations
France
Universitary Hospital - Medical Intensive Care Station
Grenoble, France, 38043
Sponsors and Collaborators
AdministrateurDRC

Responsible Party: AdministrateurDRC, Dr Maxime Lugosi, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02843880     History of Changes
Other Study ID Numbers: 2012/130
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by AdministrateurDRC, University Hospital, Grenoble:
CMV reactivation
CMV disease
Predictive factors
Critically ill patients
Septic shock

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases