Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB
REMOTE
1 other identifier
interventional
80
1 country
1
Brief Summary
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedApril 7, 2017
March 1, 2017
2 years
June 16, 2015
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cytokine levels following CPB
Evaluation of cytokine adsorber effect on cytokine levels intra- and post
72 hours
Secondary Outcomes (7)
Intra- and postoperative catecholamine dosages
until ICU discharge, expected average 4 days
postoperative renal failure necessitating RRT
until ICU discharge, expected average 4 days
Level of ferritin
72 hours
Level of transferrin
72 hours
Level of haptoglobin
72 hours
- +2 more secondary outcomes
Other Outcomes (1)
Mortality
28 days
Study Arms (2)
Treatment
EXPERIMENTALCPB with Cytosorb
Control
NO INTERVENTIONCPB without Cytosorb (Control)
Interventions
Eligibility Criteria
You may qualify if:
- Elective cardiac surgery with CPB
- 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
You may not qualify if:
- Age \< 65 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klinikum Nürnberglead
- CytoSorbents, Inccollaborator
Study Sites (1)
Klinikum Nürnberg - Nuremberg Hospital
Nuremberg, Bavaria, 90471, Germany
Related Publications (5)
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.
PMID: 12607717BACKGROUNDAllan 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.
PMID: 20829561BACKGROUNDBellomo 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.
PMID: 18311733BACKGROUNDBlomquist 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.
PMID: 19567543BACKGROUNDPeng 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.
PMID: 21918497BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD, Dr. med
Study Record Dates
First Submitted
June 16, 2015
First Posted
April 7, 2017
Study Start
May 1, 2017
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
April 7, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share