Cytokine Removal in Cardiopulmonary Bypass Patients

NCT01879176 | Completed Phase 3 Results

• 1 other identifier: 1095/2013
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Cardiac Surgical Interventions

Outcome Measures

Primary Outcomes (1)

• IL-6

  1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours

Study Arms (2)

CytoSorb

EXPERIMENTAL

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 .

Device: CytoSorb

Control

NO INTERVENTION

No filter will be installed on the CPB machine.

Interventions

CytoSorb DEVICE

Also known as: Polymer Based Adsorption Systems, ISO 13485:2003

CytoSorb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• CytoSorbents, Inc: collaborator

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

Related Publications (2)

• 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.

  PMID: 27059056 RESULT

• 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.

  PMID: 32414386 DERIVED

Results Point of Contact

• Title: Dr. Martin H. Bernardi
• Organization: Medical University of Vienna

martin.bernardi@meduniwien.ac.at

004314040041090

Study Officials

• Michael Hiesmayr, MD

  Medical University of Vienna

  STUDY DIRECTOR

• Martin H Bernardi, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Harald Rinösl, MD

  Medical University of Vienna

  STUDY CHAIR

• Friedrich Hoffelner

  General Hospital of Vienna

  STUDY CHAIR

• Andreas Spittler, MD

  Medical University of Vienna

  STUDY DIRECTOR

• Dominik Wiedemann, MD

  Medical University of Vienna

  STUDY CHAIR

• Philipp Opfermann, MD

  Medical University of Vienna

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 17, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)