NCT03266302

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infective Endocarditis

Interventions

Type	Name	Description
DEVICE	hemoadsorber 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.

Timeline

• Start date: 2018-01-17
• Primary completion: 2020-02-28
• Completion: 2020-12-31
• First posted: 2017-08-30
• Last updated: 2025-03-18

Locations

14 sites across 1 country: Germany