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

Terminated

• Conditions: CMV Infection

• Registration Number: NCT02843880
• Lead Sponsor: AdministrateurDRC

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-03-23
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	Day 28
Length of ICU stay	About 90 days
Duration of mechanical ventilation	About 90 days
Occurence of nosocomial infections	About 90 days

Trial Locations

Locations (1)

Universitary Hospital - Medical Intensive Care Station; 🇫🇷 Grenoble, France