Cytokine Removal in Cardiopulmonary Bypass Patients

Phase 3

Completed

• Conditions: Elective Cardiac Surgical Interventions
• Interventions: Device: CytoSorb

• Registration Number: NCT01879176
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Patients, who have an elective cardiac surgical intervention with an expected CBP duration \>120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent.

Patients, who decline will be asked to collect their secondary outcome data to create a "real - life" group and increase the number of patients in the control group. In this "real - life" group no additional blood samples will be taken.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Study Start: 2013-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-04-30
• Results First Submitted QC: 2016-11-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Results First Posted: 2017-01-10
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• elective cardiac surgical intervention with an expected CBP duration >120 minutes

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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-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
• CRP > 2mg/dl
• History of Stroke
• Bilirubin >2mg/dl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CytoSorb	CytoSorb	For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .

Primary Outcome Measures

Name	Time	Method
IL-6	1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours

Trial Locations

Locations (1)

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna; 🇦🇹 Vienna, Austria