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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infective Endocarditis
- Sponsor
- Jena University Hospital
- Enrollment
- 288
- Locations
- 14
- Primary Endpoint
- SOFA Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
SOFA Score
Time Frame: 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 Outcomes
- Days on ventilator, vasopressor and renal replacement therapy(until day 30 post-surgery)
- Overall mortality rate(until day 30 post surgery)
- SOFA subscores(24 hours before surgery until day 9 post-surgery)
- length of ICU and in-hospital stay(until day 30 post-surgery)
- Changes in cytokine and cfDNA levels(24 hours before, during cardiac surgery and 24 hours after surgery)
- incidence of stroke(until day 30 post-surgery)