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Cytomegalovirus Reactivation in Non Immunocompromised Patients Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02527291
Recruitment Status : Unknown
Verified March 2016 by Ori Galante, Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : August 18, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ori Galante, Soroka University Medical Center

Brief Summary:

We hypothesized that the stress of cardiac surgery and cardiopulmonary bypass can cause reactivation of a latent CMV infection and that reactivation might be more prevalent in patients with complicated post-operative course. The study aims are:

  • To study whether cardiac surgery is a trigger for latent CMV reactivation and to compare reactivation rate between sub groups of patient with complicated post-operative course and non complicated post operative course.
  • To study the relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery.

Condition or disease Intervention/treatment
Cardiac Surgery Other: Blood test

Detailed Description:

The study population will be screened at the cardiothorathic surgery ward Soroka Medical Center. A member of the study research team will approach individual subjects who are potential candidates (if all inclusion criteria are fulfilled and if there are no exclusion criteria) for participation in the study. The study member will explain the purpose, procedures and intent of the study to each potential participant. Interested patients will be asked to provide written consent prior to performing any study procedure. Each patient will be associated to one group, according to the CMV test results, which will be done at the enrollment.

Study Group - the Study group will comprise of seropositive CMV patients undergoing cardiothorathic surgery and having a complicated postoperative course.

Control Group 1 - the first control group will be comprised of patients who are seropositive CMV undergoing cardiothorathic surgery and having a normal postoperative course.

Control Group 2 - the second control group will include seronegative patients for CMV undergoing cardiothorathic surgery with complicated and uncomplicated post-operative course.

Visit 1 - Screening and enrollment:

After the patient will provide written inform consent data collection will be done by a study member and includes: demographics, clinical and medical information. In addition, vital signs will be taken and blood work: CMV Ab, CMV PCR, CBC, INR, Chemistry and IL28.

Visit 2 - follow up (on the 7th post operative day):

For patients with uncomplicated post operative (post op) course follow up at the cartiothorathic post op clinic one week after discharge. In addition to the routine blood works and medical follow up, a second blood test panel will be drowned including a second CMV PCR for the control group 1. For those patients with complicated post-operative course and prolonged hospitalization a follow up will be done in the cardiothorathic ward and will include medical tracking and blood test for a second CMV PCR for the study group. For control group 2: medical follow up and routine blood works.

Visit 3- follow up 2 (on the 14 th post operative day):

This visit is a follow up for patients still hospitalized post operatively. We will keep medical tracking and draw the last blood test for the 3rd CMV PCR for the study group. For control groups 1 and 2: medical follow up and routine blood works.

Visit 4 - follow up 3 (90 days post op):

Data collection from computerized medical records for all patients.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cytomegalovirus Reactivation in Non Immunocompromised Patients Undergoing Cardiac Surgery
Study Start Date : November 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Study Group

The Study group will comprise of seropositive CMV patients undergoing cardiothorathic surgery and having a complicated postoperative course.

In addition to the routine blood work which includes: CBC, chemistry and INR, blood work for CMV PCR will be done three times: at enrollment, follow up 1 (7 days post operation) and follow up 2 (14 days post operation).

Blood work for Interleukin28 (IL28) will be done at enrollment. All visits include data collection from computerized medical records.

Other: Blood test
Blood test for CMV PCR and IL28

Control Group 1

The first control group will be comprised of patients who are seropositive CMV undergoing cardiothorathic surgery and having a normal postoperative course.

In addition to the routine blood work which includes: CBC, chemistry and INR, blood work for CMV PCR will be done two times: at enrollment and follow up 1 (7 days after discharge).

Blood work for Interleukin28 (IL28) will be done at enrollment. All visits include data collection from computerized medical records.

Other: Blood test
Blood test for CMV PCR and IL28

Control Group 2

The second control group will include seronegative patients for CMV undergoing cardiothorathic surgery with complicated and uncomplicated post-operative course.

Blood work for CMV PCR and IL28 will be done at enrollment. All other visits include data collection from computerized medical records only.

Other: Blood test
Blood test for CMV PCR and IL28




Primary Outcome Measures :
  1. The cumulative of death, prolonged hospitalization, prolonged post-operative mechanical ventilation and prolonged use of vasopressors [ Time Frame: 12 months ]
  2. CMV reactivation: viral load elevation comparing to the baseline level prior to surgery [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Blood work: Cytomegalovirus Ab (CMV Ab), Cytomegalovirus Polymerase Chain Reaction (CMV PCR) and Interleukin (IL28).


Information from the National Library of Medicine

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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
The study population will be screened at the cardiothorathic surgery ward Soroka Medical Center.
Criteria

Inclusion Criteria:

  1. Patients admitted for cardiac surgery.
  2. Age 18 and above.

Exclusion Criteria:

1. Immunosuppressed patients including: HIV, active cancer, biological chemotherapy, steroid use equivalent to prednisone dosage above 1 mg/Kg a day, post organ transplantation.


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): NCT02527291


Contacts
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Contact: Ori Galante, MD ori.galante@gmail.com

Locations
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Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel
Contact: Ori Galante, MD         
Sponsors and Collaborators
Soroka University Medical Center
Publications of Results:
Razonable, RR, Limaye, RR. Cytomegalovirus infection after solid organ transplantation. In: Transplant Infections, 3rd ed, Bowden, RA, Ljungman, P, Snydman, DR (Eds), Lippincott Williams and Wilkins, Philadelphia 2010
Gavalda, J, Roman, A, Pahissa, A. Risks and epidemiology of infections after lung or heart-lung transplantation. In: Transplant Infections, 3rd edition, Bowden, RA, Ljungman, P, Snydman, DR (Eds), Lippincott Williams and Wilkins, Philadelphia 2010

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Responsible Party: Ori Galante, Dr. Ori Galante, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02527291    
Other Study ID Numbers: SOR-0231-15-CTIL
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Ori Galante, Soroka University Medical Center:
Cytomegalovirus
Interleukin
Polymerase Chain Reaction
CMV antibodies