Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial

Abstract

IntroductionVasoplegia is a common complication after cardiac surgery and is associated with poor prognosis. It is characterised by refractory hypotension despite normal or even increased cardiac output. The pathophysiology is complex and includes the systemic inflammatory response caused by cardiopulmonary bypass (CPB) and surgical trauma. Patients with end-stage heart failure (HF) are at increased risk for developing vasoplegia. The CytoSorb adsorber is a relatively new haemoadsorption device which can remove circulating inflammatory mediators in a concentration based manner. The CytoSorb-HF trial aims to evaluate the efficacy of CytoSorb haemoadsorption in limiting the systemic inflammatory response and preventing postoperative vasoplegia in HF patients undergoing cardiac surgery with CPB.Methods and analysisThis is an investigator-initiated, single-centre, randomised, controlled clinical trial. In total 36 HF patients undergoing elective cardiac surgery with an expected CPB duration of more than 120 min will be randomised to receive CytoSorb haemoadsorption along with standard surgical treatment or standard surgical treatment alone. The primary endpoint is the change in systemic vascular resistance index with phenylephrine challenge after CPB. Secondary endpoints include inflammatory markers, sublingual microcirculation parameters and 30-day clinical indices. In addition, we will assess the cost-effectiveness of using the CytoSorb adsorber. Vascular reactivity in response to phenylephrine challenge will be assessed after induction, after CPB and on postoperative day 1. At the same time points, and before induction and on postoperative day 4 (5 time points in total), blood samples will be collected and the sublingual microcirculation will be recorded. Study participants will be followed up until day 30.Ethics and disseminationThe trial protocol was approved by the Medical Ethical Committee of Leiden The Hague Delft (METC LDD, registration number P20.039). The results of the trial will be published in peer-reviewed medical journals and through scientific conferences.Trial registration numberNCT04812717.

Severe Refractory Vasoplegic Shock Syndrome after OPCABG Successfully Treated with Hydroxycobalamin: A Case Report and Review of the Literature

“…LVEF < 35–40%, in fact, is an independent predictor of vasoplegia after cardiac surgery with CPB. A pre-existing, increased inflammatory profile along with the compensatory chronic activation of the sympathetic nervous system and the renin–angiotensin–aldosterone system may be responsible for the development of postoperative vasoplegia in patients with heart failure [ 10 ].…”

Severe Refractory Vasoplegic Shock Syndrome After OPCABG: Our Experience and Review of Literature

“…LVEF < 35-40%, in fact, is an independent predictor of vasoplegia after cardiac surgery with CPB. A pre-existing, increased inflammatory profile along with the compensatory chronic activation of the sympathetic nervous system and the reninangiotensin-aldosterone system may be responsible for the development of postoperative vasoplegia in patients with heart failure [10].…”

Impact of CytoSorb® on interleukin-6 in cardiac surgery

“…This hyperactivation may result in a systemic inflammatory response syndrome (SIRS) and consequently septic shock. Cytokine-induced vasodilatation and increased capillary permeability cause hemodynamic depression and organ dysfunction, linked to increased morbidity and mortality ( 3 – 5 ). Interleukin (IL-) 6 plays a crucial role as early indicator of inflammation prior to C-reactive protein (CRP) and is therefore routinely used in the intensive care setting ( 6 ).…”