Cytokine Removal in Cardiopulmonary Bypass Patients

NCT ID: NCT01879176

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-05-31

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.

Conditions

Elective Cardiac Surgical Interventions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 .

Group Type: EXPERIMENTAL

CytoSorb

Intervention Type: DEVICE

Control

No filter will be installed on the CPB machine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CytoSorb

Intervention Type: DEVICE

Other Intervention Names

Polymer Based Adsorption Systems; ISO 13485:2003

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytoSorbents, Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Martin Bernardi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Hiesmayr, MD

Role: STUDY_DIRECTOR

Medical University of Vienna

Martin H Bernardi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Harald Rinösl, MD

Role: STUDY_CHAIR

Medical University of Vienna

Friedrich Hoffelner

Role: STUDY_CHAIR

General Hospital of Vienna

Andreas Spittler, MD

Role: STUDY_DIRECTOR

Medical University of Vienna

Dominik Wiedemann, MD

Role: STUDY_CHAIR

Medical University of Vienna

Philipp Opfermann, MD

Role: STUDY_CHAIR

Medical University of Vienna

Locations

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

References

Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.

Reference Type: RESULT

PMID: 27059056 (View on PubMed)

Wisgrill L, Lamm C, Hell L, Thaler J, Berger A, Weiss R, Weber V, Rinoesl H, Hiesmayr MJ, Spittler A, Bernardi MH. Influence of hemoadsorption during cardiopulmonary bypass on blood vesicle count and function. J Transl Med. 2020 May 15;18(1):202. doi: 10.1186/s12967-020-02369-x.

Reference Type: DERIVED

PMID: 32414386 (View on PubMed)

Other Identifiers

1095/2013

Identifier Type: -

Identifier Source: org_study_id