Clinical trial NCT01879176: Cytokine Removal in Cardiopulmonary Bypass Patients
Official title: Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elective Cardiac Surgical Interventions
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: CytoSorbents, Inc
First posted: 2013-06-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: IL-6
timeFrame: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Michael Hiesmayr, MD
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Martin H Bernardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Harald Rinösl, MD
role: STUDY_CHAIR
affiliation: General Hospital of Vienna
name: Friedrich Hoffelner
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Andreas Spittler, MD
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Dominik Wiedemann, MD
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Philipp Opfermann, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.