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

Jena University Hospital

Status: Completed

Conditions: Infective Endocarditis

Treatments: Device: hemoadsorber for removal of cytokines

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03266302

ZKSJ0108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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288 participants in 2 patient groups

Interventional group

Experimental group

Description:

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)

Treatment:

Device: hemoadsorber for removal of cytokines

Control group

No Intervention group

Description:

Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)