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CMV Intensive Care Units

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ClinicalTrials.gov Identifier: NCT02324244
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Emilio Bouza, Hospital General Universitario Gregorio Marañon

Brief Summary:
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.

Condition or disease
CMV Infection

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Monitoring Study of Cytomegalovirus Infection in Immunocompetent Critical Heart Surgery Patients
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Group/Cohort
immunocompetent patients underwent heart surgery



Primary Outcome Measures :
  1. incidence number of participants with a positive CMV positive result [ Time Frame: month 8 ]

Secondary Outcome Measures :
  1. risk factors for CMV reactivation [ Time Frame: month 8 ]
  2. mortality by day 30 [ Time Frame: month 8 ]
    composite endpoint. hospitalization or death by day 30

  3. prolonged hospitalization . More than 30 days [ Time Frame: month 8 ]

Biospecimen Retention:   Samples With DNA
plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
immunocompetent adults admitted to a major heart surgery intensive care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324244


Locations
Spain
Servicio de Microbiologia y Enfermedades Infecciosas
Madrid, Spain, 28007
Sponsors and Collaborators
Emilio Bouza
Investigators
Principal Investigator: Patricia Muñoz, PhD Hospital General Universitario Gregorio Marañon

Responsible Party: Emilio Bouza, Head of Department, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02324244     History of Changes
Other Study ID Numbers: MICRO.HGUGM.2014-006
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

Keywords provided by Emilio Bouza, Hospital General Universitario Gregorio Marañon:
Cytomegalovirus
critical patient
ICU
immunocompetent
clinical suspicion
risk factors

Additional relevant MeSH terms:
Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases