CMV Intensive Care Units

December 23, 2014 updated by: Emilio Bouza

A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients

Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.

Study Overview

Status

Completed

Conditions

CMV Infection

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Madrid, Spain, 28007
    - Servicio de Microbiologia y Enfermedades Infecciosas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

immunocompetent adults admitted to a major heart surgery intensive care unit

Description

Inclusion Criteria:

Agreeing to participate in the study
Age of at least 18 years
Admission to the MHS-ICU for at least 72 hours

Exclusion Criteria:

Inability to give informed consent
Age younger than 18 years
AIDS
Pregnancy
Organ or bone marrow transplant, receipt of immunosuppressive therapy including corticosteroids within 30 days, and cancer or hematologic malignancy treated with radiotherapy or chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
immunocompetent patients underwent heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence number of participants with a positive CMV positive result Time Frame: month 8	month 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors for CMV reactivation Time Frame: month 8		month 8
mortality by day 30 Time Frame: month 8	composite endpoint. hospitalization or death by day 30	month 8
prolonged hospitalization . More than 30 days Time Frame: month 8		month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emilio Bouza

Investigators

Principal Investigator: Patricia Muñoz, PhD, Hospital General Universitario Gregorio Marañon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)