Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis

Study Overview
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Brief Summary
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Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.

Detailed Description
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The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.

Official Title
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Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial

Conditions
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Infective Endocarditis

Intervention / Treatment
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* Device: hemoadsorber for removal of cytokines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery informed consent age ≥18 years Exclusion Criteria: EuroScoreII ≤ 3 current participation in another interventional Trial pregnancy current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold) previous participation in the REMOVE study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Use of hemoadsorber for removal of cytokines. Participants undergoing cardiac surgery due to infective endocarditis will be treated using a hemoadsorption device (CytoSorb) within the cardiopulmonary Bypass circuit (=Intervention) | Device: hemoadsorber for removal of cytokines<br>* Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.<br>* Other names: CytoSorb(R);|
| No Intervention: Control group<br>Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA Score | The investigators will test if mean SOFA scores are different for the experimental and control group. | 24 hours before until day 9 post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality rate | Overall mortality rate until day 30 post-surgery | until day 30 post surgery | 
| Changes in cytokine and cfDNA levels | changes in cytokine and cfDNA levels will be measured at different time points before, during and after surgery in both groups; only for the first 2x25 patients | 24 hours before, during cardiac surgery and 24 hours after surgery | 
| SOFA subscores | single SOFA subscores will be analyzed | 24 hours before surgery until day 9 post-surgery | 
| Days on ventilator, vasopressor and renal replacement therapy | Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed | until day 30 post-surgery | 
| incidence of stroke | incidence of stroke within 30 days post-surgery will be assessed | until day 30 post-surgery | 
| length of ICU and in-hospital stay | total length of ICU and in-hospital stay until day 30 post-surgery | until day 30 post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytokines, vasodilatory shock, hemoadsorption, cardiac surgery