Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial
Introduction Vasoplegia 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 cardio...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e061337.full |
| _version_ | 1811239021153615872 |
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| author | Can Ince Jan H N Lindeman Wilbert B van den Hout Saskia L M A Beeres Robert J M Klautz Olga Papazisi Eline F Bruggemans Remco R Berendsen Juan D V Hugo M Sesmu Arbous Bart J A Mertens Meindert Palmen |
| author_facet | Can Ince Jan H N Lindeman Wilbert B van den Hout Saskia L M A Beeres Robert J M Klautz Olga Papazisi Eline F Bruggemans Remco R Berendsen Juan D V Hugo M Sesmu Arbous Bart J A Mertens Meindert Palmen |
| author_sort | Can Ince |
| collection | DOAJ |
| description | Introduction Vasoplegia 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 analysis This 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 dissemination The 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 number NCT04812717. |
| first_indexed | 2024-04-12T12:52:31Z |
| format | Article |
| id | doaj.art-61258d57f9d64b6eb42489aef7f5c94f |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-12T12:52:31Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-61258d57f9d64b6eb42489aef7f5c94f2022-12-22T03:32:25ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-061337Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trialCan Ince0Jan H N Lindeman1Wilbert B van den Hout2Saskia L M A Beeres3Robert J M Klautz4Olga Papazisi5Eline F Bruggemans6Remco R Berendsen7Juan D V Hugo8M Sesmu Arbous9Bart J A Mertens10Meindert Palmen11Department of Intensive Care, Laboratory of Translational Intensive Care, Erasmus University Rotterdam, Rotterdam, The NetherlandsDepartment of Vascular Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiology, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Anaesthesiology, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Intensive Care, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The NetherlandsIntroduction Vasoplegia 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 analysis This 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 dissemination The 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 number NCT04812717.https://bmjopen.bmj.com/content/12/9/e061337.full |
| spellingShingle | Can Ince Jan H N Lindeman Wilbert B van den Hout Saskia L M A Beeres Robert J M Klautz Olga Papazisi Eline F Bruggemans Remco R Berendsen Juan D V Hugo M Sesmu Arbous Bart J A Mertens Meindert Palmen Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial BMJ Open |
| title | Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial |
| title_full | Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial |
| title_fullStr | Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial |
| title_full_unstemmed | Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial |
| title_short | Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial |
| title_sort | prevention of vasoplegia with cytosorb in heart failure patients undergoing cardiac surgery cytosorb hf trial protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/9/e061337.full |
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