NCT02527291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 25, 2022

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

August 17, 2015

Last Update Submit

October 24, 2022

Conditions

Cardiac Surgery

Keywords

CytomegalovirusInterleukinPolymerase Chain ReactionCMV antibodies

Outcome Measures

Primary Outcomes (2)

  • The cumulative of death, prolonged hospitalization, prolonged post-operative mechanical ventilation and prolonged use of vasopressors

    12 months

  • CMV reactivation: viral load elevation comparing to the baseline level prior to surgery

    12 months

Secondary Outcomes (1)

  • The relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery.

    12 months

Study Arms (3)

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

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

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

Interventions

Blood testOTHER

Blood test for CMV PCR and IL28

Control Group 1Control Group 2Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients admitted for cardiac surgery.
  • Age 18 and above.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (14)

  • Staras SA, Dollard SC, Radford KW, Flanders WD, Pass RF, Cannon MJ. Seroprevalence of cytomegalovirus infection in the United States, 1988-1994. Clin Infect Dis. 2006 Nov 1;43(9):1143-51. doi: 10.1086/508173. Epub 2006 Oct 2.

    PMID: 17029132RESULT

  • 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

    RESULT

  • 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

    RESULT

  • Heininger A, Jahn G, Engel C, Notheisen T, Unertl K, Hamprecht K. Human cytomegalovirus infections in nonimmunosuppressed critically ill patients. Crit Care Med. 2001 Mar;29(3):541-7. doi: 10.1097/00003246-200103000-00012.

    PMID: 11373417RESULT

  • Jaber S, Chanques G, Borry J, Souche B, Verdier R, Perrigault PF, Eledjam JJ. Cytomegalovirus infection in critically ill patients: associated factors and consequences. Chest. 2005 Jan;127(1):233-41. doi: 10.1378/chest.127.1.233.

    PMID: 15653989RESULT

  • Limaye AP, Kirby KA, Rubenfeld GD, Leisenring WM, Bulger EM, Neff MJ, Gibran NS, Huang ML, Santo Hayes TK, Corey L, Boeckh M. Cytomegalovirus reactivation in critically ill immunocompetent patients. JAMA. 2008 Jul 23;300(4):413-22. doi: 10.1001/jama.300.4.413.

    PMID: 18647984RESULT

  • Kalil AC, Florescu DF. Prevalence and mortality associated with cytomegalovirus infection in nonimmunosuppressed patients in the intensive care unit. Crit Care Med. 2009 Aug;37(8):2350-8. doi: 10.1097/CCM.0b013e3181a3aa43.

    PMID: 19531944RESULT

  • Wan S, Yim AP, Ng CS, Arifi AA. Systematic organ protection in coronary artery surgery with or without cardiopulmonary bypass. J Card Surg. 2002 Nov-Dec;17(6):529-35. doi: 10.1046/j.1540-8191.2002.01010.x.

    PMID: 12643464RESULT

  • Booth D, George J. Loss of function of the new interferon IFN-lambda4 may confer protection from hepatitis C. Nat Genet. 2013 Feb;45(2):119-20. doi: 10.1038/ng.2537.

    PMID: 23358218RESULT

  • Kelly C, Klenerman P, Barnes E. Interferon lambdas: the next cytokine storm. Gut. 2011 Sep;60(9):1284-93. doi: 10.1136/gut.2010.222976. Epub 2011 Feb 8.

    PMID: 21303914RESULT

  • Rauch A, Kutalik Z, Descombes P, Cai T, Di Iulio J, Mueller T, Bochud M, Battegay M, Bernasconi E, Borovicka J, Colombo S, Cerny A, Dufour JF, Furrer H, Gunthard HF, Heim M, Hirschel B, Malinverni R, Moradpour D, Mullhaupt B, Witteck A, Beckmann JS, Berg T, Bergmann S, Negro F, Telenti A, Bochud PY; Swiss Hepatitis C Cohort Study; Swiss HIV Cohort Study. Genetic variation in IL28B is associated with chronic hepatitis C and treatment failure: a genome-wide association study. Gastroenterology. 2010 Apr;138(4):1338-45, 1345.e1-7. doi: 10.1053/j.gastro.2009.12.056. Epub 2010 Jan 11.

    PMID: 20060832RESULT

  • Tanaka Y, Nishida N, Sugiyama M, Kurosaki M, Matsuura K, Sakamoto N, Nakagawa M, Korenaga M, Hino K, Hige S, Ito Y, Mita E, Tanaka E, Mochida S, Murawaki Y, Honda M, Sakai A, Hiasa Y, Nishiguchi S, Koike A, Sakaida I, Imamura M, Ito K, Yano K, Masaki N, Sugauchi F, Izumi N, Tokunaga K, Mizokami M. Genome-wide association of IL28B with response to pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C. Nat Genet. 2009 Oct;41(10):1105-9. doi: 10.1038/ng.449. Epub 2009 Sep 13.

    PMID: 19749757RESULT

  • Egli A, Levin A, Santer DM, Joyce M, O'Shea D, Thomas BS, Lisboa LF, Barakat K, Bhat R, Fischer KP, Houghton M, Tyrrell DL, Kumar D, Humar A. Immunomodulatory Function of Interleukin 28B during primary infection with cytomegalovirus. J Infect Dis. 2014 Sep 1;210(5):717-27. doi: 10.1093/infdis/jiu144. Epub 2014 Mar 11.

    PMID: 24620020RESULT

  • Bravo D, Solano C, Gimenez E, Remigia MJ, Corrales I, Amat P, Navarro D. Effect of the IL28B Rs12979860 C/T polymorphism on the incidence and features of active cytomegalovirus infection in allogeneic stem cell transplant patients. J Med Virol. 2014 May;86(5):838-44. doi: 10.1002/jmv.23865. Epub 2013 Dec 27.

    PMID: 24374819RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood work: Cytomegalovirus Ab (CMV Ab), Cytomegalovirus Polymerase Chain Reaction (CMV PCR) and Interleukin (IL28).

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ori Galante

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 18, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

October 25, 2022

Record last verified: 2016-03

Locations

IL(1)