Cytomegalovirus Reactivation in Non Immunocompromised Patients Undergoing Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Cytomegalovirus Reactivation in Non Immunocompromised Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527291
• Other study ID #: SOR-0231-15-CTIL
• Status: Completed
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Blood test
Blood test for CMV PCR and IL28

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (14)

Booth D, George J. Loss of function of the new interferon IFN-?4 may confer protection from hepatitis C. Nat Genet. 2013 Feb;45(2):119-20. doi: 10.1038/ng.2537. — View Citation

Bravo D, Solano C, Giménez 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;8 — View Citation

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 Se — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

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, Günthard HF, Heim M, Hirschel B, Malinverni R, Moradpour D, Müllhaupt B, Witteck A, Beckmann JS, Berg — View Citation

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

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. Epub 2006 Oct 2. — View Citation

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, S — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative of death, prolonged hospitalization, prolonged post-operative mechanical ventilation and prolonged use of vasopressors		12 months
Primary	CMV reactivation: viral load elevation comparing to the baseline level prior to surgery		12 months
Secondary	The relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery.		12 months