Elective Cardiac Surgical Interventions Clinical Trial
— CytoSorbOfficial title:
EFFECT OF CYTOKINE REMOVAL IN CARDIOPULMONARY BYPASS PATIENTS USING THE CYTOSORB ™ FILTER
Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by
extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,
endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,
ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in
systemic inflammation and the main producers of pro- and antiinflammatory cytokines.
Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory
homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6
and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory
response induces post surgical monocyte immunosuppression which is indicated by an impaired
production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral
circulation with increased lactate levels, pronounced fluid accumulation, increased need of
vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning
from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to
decrease the inflammatory process have the potential to improve the perioperative course.
Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels
for the first 36 hours after surgery and induces a decreased inflammatory response for up to
3 days post surgery.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - elective cardiac surgical intervention with an expected CBP duration >120 minutes Exclusion Criteria: - Emergency procedures - Heart transplantation - Elective left ventricular assist device (LVAD) implantation - Pulmonary thromendarterectomy - Declined informed consent - Serum creatinine > 2mg/dl - Body mass index < 18 - Age < 18 years - Pregnant woman - Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia - Receiving antileukocyte drugs - Receiving TNF-a Blockers, immunosuppressive drugs (e.g. tocilizumab) - CRP > 2mg/dl - History of Stroke - Bilirubin >2mg/dl |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna | CytoSorbents, Inc |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Drug treatment | Vasopressor dose Insulin dose |
1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No |
| Other | Volemic status | Need of fluid components (crystalloid, colloid solutions) Need of blood products (erythrocytes, fresh frozen plasma, platelets) Body impedance Body weight |
1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No |
| Other | Changes in procalcitonin, albumin, fibrinogen and total blood count | 1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No | |
| Other | • Length of ICU stay | participants will be followed for the duration of ICU stay | No | |
| Other | 30 days mortality | at day 30 | No | |
| Primary | Evolution of cytokines IL-1ß, IL-6, IL-18, TNF-a, IL-10 | 1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No | |
| Secondary | Serum CRP changes | 1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No | |
| Secondary | ex vivo LPS induced TNF-a production | 1. At induction of anaesthesia 2. Start CBP 3. At the end of CPB 4. 2 hours 5. 24 hours 6. 48 hours 7. 120 - 168 hours | No |