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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Other | Blood test for CMV PCR and IL28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery. | 12 months |
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Inclusion Criteria:
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.
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The study population will be screened at the cardiothorathic surgery ward Soroka Medical Center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Beersheba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17029132 | Result | 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. | |
| Result | 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 | ||
| 11373417 |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood work: Cytomegalovirus Ab (CMV Ab), Cytomegalovirus Polymerase Chain Reaction (CMV PCR) and Interleukin (IL28).
| 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. |
| 15653989 | Result | 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. |
| 18647984 | Result | 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. |
| 19531944 | Result | 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. |
| 12643464 | Result | 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. |
| 23358218 | Result | 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. |
| 21303914 | Result | 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. |
| 20060832 | Result | 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. |
| 19749757 | Result | 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. |
| 24620020 | Result | 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. |
| 24374819 | Result | 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. |