Clinical trial NCT02843880: Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study
Official title: Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CMV Infection
Keywords: CMV reactivation
CMV disease
Predictive factors
Critically ill patients
Septic shock
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Occurrence of CMV disease
timeFrame: From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)
Secondary outcomes:
measure: Mortality
timeFrame: Day 28
measure: Length of ICU stay
timeFrame: About 90 days
measure: Duration of mechanical ventilation
timeFrame: About 90 days
measure: Occurence of nosocomial infections
timeFrame: About 90 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Universitary Hospital - Medical Intensive Care Station
Study officials:
References: