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Recruitment Status : Terminated (Problematic has become outdated in relation with current litterature advances.)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
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|
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|
|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|
|Primary Completion Date :||May 2016|
|Study Completion Date :||May 2016|
Septic shock patients
Septic shock patients staying over 3 days mechanically ventilated in the ICU
- 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
- Mortality [ Time Frame: Day 28 ]
- Length of ICU stay [ Time Frame: About 90 days ]
- Duration of mechanical ventilation [ Time Frame: About 90 days ]
- Occurence of nosocomial infections [ Time Frame: About 90 days ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843880
|Universitary Hospital - Medical Intensive Care Station|
|Grenoble, France, 38043|