Status:
COMPLETED
Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
CytoSorbents, Inc
Thermo Fisher Scientific, Inc
Conditions:
Infective Endocarditis
Eligibility:
All Genders
18+ years
Phase:
NA
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 unde...
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.
Eligibility Criteria
Inclusion
- patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
- informed consent
- age ≥18 years
Exclusion
- 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
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT03266302
Start Date
January 17 2018
End Date
December 31 2020
Last Update
March 18 2025
Active Locations (14)
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1
University Heart Center Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany, D-79189
2
University Heart Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, D-79106
3
University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery
Ulm, Baden-Wurttemberg, Germany, D-89081
4
University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery
Cologne, North Rhine-Westphalia, Germany, D-50937