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Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb | Active Comparator | Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery. |
|
| Control | Sham Comparator | Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb | Device | The hemadsorption filter will be included in the CPB circuit between the oxygenator and the venous reservoir. After cardiac surgery, the use of the filter will be continued till 24 hours after the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 concentration at ICU admission | Investigators will assess the blood IL-6 concentrations between the two arms | At day 0 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 concentration before cardiac surgery | Investigators will assess the blood IL-6 concentrations between the two arms | At day 0 before the cardiac surgery |
| IL-6 concentration at the end of CardioPulmonary Bypass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe F Serraino, MD | Contact | 0039 0961 3647033 | filiberto@live.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Serraino, MD | Magna Graecia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Mater Domini | Catanzaro | CZ | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16738019 | Background | Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006 Jul;17(7):2034-47. doi: 10.1681/ASN.2005101085. Epub 2006 May 31. | |
| 12173816 | Background | Penta de Peppo A, Nardi P, De Paulis R, Pellegrino A, Forlani S, Scafuri A, Chiariello L. Cardiac surgery in moderate to end-stage renal failure: analysis of risk factors. Ann Thorac Surg. 2002 Aug;74(2):378-83. doi: 10.1016/s0003-4975(02)03711-6. |
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The full protocol, datasets used and analysed during the current study will be available on reasonable request after study publication
After scientific publication
On reasonable request
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Control | Device | No hemadsorption filter or other treatment will be included in the CPB circuit |
|
Investigators will assess the blood IL-6 concentrations between the two arms
| At day 0 at the end of the CardioPulmonary Bypass |
| IL-6 concentration 2 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms | 2 hours after the end of CardioPulmonary Bypass |
| IL-6 concentration 48 hours after the end of CardioPulmonary Bypass | Investigators will assess the blood IL-6 concentrations between the two arms | 48 hours after the end of CardioPulmonary Bypass |
| Renal function | Investigators will assess the blood creatinine concentrations in the two arms | daily up to day 15 |
| Myoglobin concentration | Investigators will assess the blood myoglobin concentrations in the two arms | daily up to day 15 |
| Haptoglobin concentration | Investigators will assess the blood haptoglobin concentrations in the two arms | daily up to day 15 |
| Liver transaminases concentration | Investigators will measure the liver transaminases concentrations in the two arms to assess any liver injury | daily up to day 15 |
| Osteopontin concentration | Investigators will measure the osteopontin concentrations in the two arms to assess the inflammatory status | daily up to day 15 |
| Free hemoglobin concentration | Investigators will assess the free hemoglobin concentrations in the two arms | daily up to day 15 |
| 10425004 | Background | Durmaz I, Buket S, Atay Y, Yagdi T, Ozbaran M, Boga M, Alat I, Guzelant A, Basarir S. Cardiac surgery with cardiopulmonary bypass in patients with chronic renal failure. J Thorac Cardiovasc Surg. 1999 Aug;118(2):306-15. doi: 10.1016/S0022-5223(99)70221-7. |
| 12776273 | Background | Pecoits-Filho R, Heimburger O, Barany P, Suliman M, Fehrman-Ekholm I, Lindholm B, Stenvinkel P. Associations between circulating inflammatory markers and residual renal function in CRF patients. Am J Kidney Dis. 2003 Jun;41(6):1212-8. doi: 10.1016/s0272-6386(03)00353-6. |
| 10843245 | Background | Takahashi T, Kubota M, Nakamura T, Ebihara I, Koide H. Interleukin-6 gene expression in peripheral blood mononuclear cells from patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Ren Fail. 2000 May;22(3):345-54. doi: 10.1081/jdi-100100878. |
| 12234313 | Background | Caglar K, Peng Y, Pupim LB, Flakoll PJ, Levenhagen D, Hakim RM, Ikizler TA. Inflammatory signals associated with hemodialysis. Kidney Int. 2002 Oct;62(4):1408-16. doi: 10.1111/j.1523-1755.2002.kid556.x. |
| 26021321 | Background | Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Sune N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. doi: 10.2174/1871528114666150529120801. |
| 24092406 | Background | de Amorim CG, Malbouisson LM, da Silva FC Jr, Fiorelli AI, Murakami CK, Carmona MJ. Leukocyte depletion during CPB: effects on inflammation and lung function. Inflammation. 2014 Feb;37(1):196-204. doi: 10.1007/s10753-013-9730-z. |
| 15821654 | Background | Ilmakunnas M, Pesonen EJ, Ahonen J, Ramo J, Siitonen S, Repo H. Activation of neutrophils and monocytes by a leukocyte-depleting filter used throughout cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Apr;129(4):851-9. doi: 10.1016/j.jtcvs.2004.07.061. |
| 25635933 | Background | Wiegele M, Krenn CG. Cytosorb in a patient with Legionella pneumonia-associated rhabdomyolysis: a case report. ASAIO J. 2015 May-Jun;61(3):e14-6. doi: 10.1097/MAT.0000000000000197. No abstract available. |
| 25538418 | Background | Basu R, Pathak S, Goyal J, Chaudhry R, Goel RB, Barwal A. Use of a novel hemoadsorption device for cytokine removal as adjuvant therapy in a patient with septic shock with multi-organ dysfunction: A case study. Indian J Crit Care Med. 2014 Dec;18(12):822-4. doi: 10.4103/0972-5229.146321. |
| 24811308 | Background | Hetz H, Berger R, Recknagel P, Steltzer H. Septic shock secondary to beta-hemolytic streptococcus-induced necrotizing fasciitis treated with a novel cytokine adsorption therapy. Int J Artif Organs. 2014 May;37(5):422-6. doi: 10.5301/ijao.5000315. Epub 2014 Apr 17. |
| 19192755 | Background | Vercaemst L. Hemolysis in cardiac surgery patients undergoing cardiopulmonary bypass: a review in search of a treatment algorithm. J Extra Corpor Technol. 2008 Dec;40(4):257-67. |
| 24944898 | Background | Kahles F, Findeisen HM, Bruemmer D. Osteopontin: A novel regulator at the cross roads of inflammation, obesity and diabetes. Mol Metab. 2014 Mar 22;3(4):384-93. doi: 10.1016/j.molmet.2014.03.004. eCollection 2014 Jul. |
| 26971164 | Background | Baumann A, Buchwald D, Annecke T, Hellmich M, Zahn PK, Hohn A. RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial. Trials. 2016 Mar 12;17(1):137. doi: 10.1186/s13063-016-1265-9. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |