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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock

Conditions
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CMV Infection

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic shock patients<br>Septic shock patients staying over 3 days mechanically ventilated in the ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of CMV disease | CMV disease is defined by occurence of viremia and/or an organ failure | From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Day 28 | 
| Length of ICU stay |  | About 90 days | 
| Duration of mechanical ventilation |  | About 90 days | 
| Occurence of nosocomial infections |  | About 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMV reactivation, CMV disease, Predictive factors, Critically ill patients, Septic shock