Infective Endocarditis
Conditions
Keywords
vasodilatory shock, hemoadsorption, cardiac surgery, cytokines
Brief summary
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
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.
Interventions
DEVICEhemoadsorber for removal of cytokines
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
Sponsors
CytoSorbents, Inc
Thermo Fisher Scientific, Inc
Fraunhofer Institute for Interfacial Engineering and Biotechnology
German Federal Ministry of Education and Research
Jena University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participant will not be informed about group allocation
Intervention model description
two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA Score | 24 hours before until day 9 post-surgery | The investigators will test if mean SOFA scores are different for the experimental and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cytokine and cfDNA levels | 24 hours before, during cardiac surgery and 24 hours after surgery | 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 |
| SOFA subscores | 24 hours before surgery until day 9 post-surgery | single SOFA subscores will be analyzed |
| Overall mortality rate | until day 30 post surgery | Overall mortality rate until day 30 post-surgery |
| incidence of stroke | until day 30 post-surgery | incidence of stroke within 30 days post-surgery will be assessed |
| length of ICU and in-hospital stay | until day 30 post-surgery | total length of ICU and in-hospital stay until day 30 post-surgery |
| Days on ventilator, vasopressor and renal replacement therapy | until day 30 post-surgery | Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed |
Countries
Germany
Outcome results
None listed