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

Not Applicable

Completed

• Conditions: Infective Endocarditis
• Interventions: Device: hemoadsorber for removal of cytokines

• Registration Number: NCT03266302
• Lead Sponsor: Jena University Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Study Start: 2018-01-17
• Primary Completion: 2020-02-28
• Status Verified: 2020-03
• Study Completion: 2020-12-31
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Interventional group	hemoadsorber for removal of cytokines	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Overall mortality rate	until day 30 post surgery	Overall mortality rate until day 30 post-surgery
SOFA subscores	24 hours before surgery until day 9 post-surgery	single SOFA subscores will be analyzed
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
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
incidence of stroke	until day 30 post-surgery	incidence of stroke within 30 days post-surgery will be assessed

Trial Locations

Locations (14)

University Heart Center Bad Krozingen; 🇩🇪 Bad Krozingen, Baden-Württemberg, Germany

University Heart Center Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery; 🇩🇪 Cologne, North Rhine-Westphalia, Germany

University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery; 🇩🇪 Essen, North Rhine-Westphalia, Germany

Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Brandenburg, Immanuel Klinikum Bernau; 🇩🇪 Bernau bei Berlin, Germany

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie; 🇩🇪 Bochum, Germany

Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie; 🇩🇪 Bonn, Germany

Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie; 🇩🇪 Dresden, Germany

Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie; 🇩🇪 Düsseldorf, Germany

Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie; 🇩🇪 Halle (Saale), Germany

Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie; 🇩🇪 Leipzig, Germany

University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery; 🇩🇪 Ulm, Baden-Württemberg, Germany

Jena University Hospital, Dept. of Cardiac and Thoracic Surgery; 🇩🇪 Jena, Thuringia, Germany