Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB
NCT ID: NCT03104179
Last Updated: 2017-04-07
Study Results
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Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-05-31
2019-05-31
Brief Summary
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They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
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Detailed Description
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They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
Official Title: Removal of Cytokines in patients undergoing cardiac surgery with CPB ( The REMOTE Study)
Study type: Interventional Study design: randomized, controlled Endpoint Classification: Efficacy study Interventional Model: Parallel assignment Masking: Single blinding ( Subject) Primary purpose: Treatment
Patients who have an elective cardiac surgery with an expected CPB duration \> 75 min ( e.g. valve surgery, CABG, combined procedures, redo) will be enrolled into the study after a giving informed consent.
Selection of patients are directed by randomization. Patient which drop out will be replaced.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
CPB with Cytosorb
Cytosorb Adsorber
Cytokine adsorption during CPB
Control
CPB without Cytosorb (Control)
No interventions assigned to this group
Interventions
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Cytosorb Adsorber
Cytokine adsorption during CPB
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* CPB time \> 75 min.
* Comorbidities:
* diabetes mellitus
* CHF, NYHA class 1 and 2
* liver dysfunction (1, 2)
* kidney dysfunction (1, 2)
* hypertension
* arteriosclerosis
Exclusion Criteria
* Declined informed consent
* Planed temperature \< 32 C
* Emergency surgery
* Preexisting renal replacement therapy
* Preexisting kidney transplantation
* Administration of immunosuppressants like steroids
* AIDS with CD 4 \< 200/
* Participation in other trials
65 Years
85 Years
ALL
No
Sponsors
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CytoSorbents, Inc
INDUSTRY
Klinikum Nürnberg
OTHER
Responsible Party
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PD Dr. med. Giuseppe Santarpino
PD, Dr. med
Locations
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Klinikum Nürnberg - Nuremberg Hospital
Nuremberg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Levy JH, Tanaka KA. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):S715-20. doi: 10.1016/s0003-4975(02)04701-x.
Allan CK, Newburger JW, McGrath E, Elder J, Psoinos C, Laussen PC, del Nido PJ, Wypij D, McGowan FX Jr. The relationship between inflammatory activation and clinical outcome after infant cardiopulmonary bypass. Anesth Analg. 2010 Nov;111(5):1244-51. doi: 10.1213/ANE.0b013e3181f333aa. Epub 2010 Sep 9.
Bellomo R, Auriemma S, Fabbri A, D'Onofrio A, Katz N, McCullough PA, Ricci Z, Shaw A, Ronco C. The pathophysiology of cardiac surgery-associated acute kidney injury (CSA-AKI). Int J Artif Organs. 2008 Feb;31(2):166-78. doi: 10.1177/039139880803100210.
Blomquist S, Gustafsson V, Manolopoulos T, Pierre L. Clinical experience with a novel endotoxin adsorbtion device in patients undergoing cardiac surgery. Perfusion. 2009 Jan;24(1):13-7. doi: 10.1177/0267659109106730.
Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.
Other Identifiers
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1_15B
Identifier Type: -
Identifier Source: org_study_id
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