RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial

Andreas Baumann, Dirk Buchwald, Thorsten Annecke, Martin Hellmich, Peter K Zahn, Andreas Hohn, Andreas Baumann, Dirk Buchwald, Thorsten Annecke, Martin Hellmich, Peter K Zahn, Andreas Hohn

Abstract

Background: On-pump cardiac surgery triggers a significant postoperative systemic inflammatory response, sometimes resulting in multiple-organ dysfunction associated with poor clinical outcome. Extracorporeal cytokine elimination with a novel haemoadsorption (HA) device (CytoSorb®) promises to attenuate inflammatory response. This study primarily assesses the efficacy of intraoperative HA during cardiopulmonary bypass (CPB) to reduce the proinflammatory cytokine burden during and after on-pump cardiac surgery, and secondarily, we aim to evaluate effects on postoperative organ dysfunction and outcomes in patients at high risk.

Methods/design: This will be a single-centre randomised, two-arm, patient-blinded trial of intraoperative HA in patients undergoing on-pump cardiac surgery. Subjects will be allocated to receive either CPB with intraoperative HA or standard CPB without HA. The primary outcome is the difference in mean interleukin 6 (IL-6) serum levels between the two study groups on admission to the intensive care unit. A total number of 40 subjects was calculated as necessary to detect a clinically relevant 30 % reduction in postoperative IL-6 levels. Secondary objectives evaluate effects of HA on markers of inflammation up to 48 hours postoperatively, damage to the endothelial glycocalyx and effects on clinical scores and parameters of postoperative organ dysfunction and outcomes.

Discussion: In this pilot trial we try to assess whether intraoperative HA with CytoSorb® can relevantly reduce postoperative IL-6 levels in patients undergoing on-pump cardiac surgery. Differences in secondary outcome variables between the study groups may give rise to further studies and may lead to a better understanding of the mechanisms of haemoadsorption.

Trial registration: German Clinical Trials Register number DRKS00007928 (Date of registration 3 Aug 2015).

Keywords: Cardiac surgery; Cardiopulmonary bypass; Cytokines; Glycocalyx shedding; Haemoadsorption; Inflammation.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the REmoval of Cytokines during CArdiac Surgery (RECCAS) trial. A single-centre randomised, two-arm, controlled, patient-blinded trial of the effects of intraoperative haemoadsorption on postoperative inflammatory response and organ dysfunction in patients undergoing on-pump cardiac surgery
Fig. 2
Fig. 2
Integration of the haemoadsorption device into the cardiopulmonary bypass (CPB) circuit. Oxygenated blood is taken from the oxygenator of the heart-lung machine (HLM), and an additional blood pump ensures a defined blood flow of 400 mL/min through the adsorber to the venous reservoir of the HLM

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