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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02843880

Acronym

CMV-Réa

Enrollment

Registered

2016-07-26

Start date

2013-03-31

Completion date

2016-05-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV Infection

Keywords

CMV reactivation, CMV disease, Predictive factors, Critically ill patients, Septic shock

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of CMV disease	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

Measure	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

Countries

France

Outcome results