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

Not Applicable

• Conditions: I33.0; Acute and subacute infective endocarditis

• Registration Number: DRKS00013740
• Lead Sponsor: Center for Sepsis Control & Care Universitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study Completion: 2020-02-28
• Results First Posted: 2022-02-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1) Patients with IE (infective endocarditis) (according to Duke criteria) undergoing cardiac surgery
2) Informed consent
3) Age = 18 years

Exclusion Criteria

1) EuroScoreII = 3
2) Current participation in another interventional trial
3) Pregnancy
4) Current immunosupressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)
5) Previous participation in the REMOVE study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Organ failure determined by SOFA score (delta mean total SOFA score before surgery and day 9 post-surgery)

Secondary Outcome Measures

Name	Time	Method
1) 30-day mortality rate <br>2) Changes in vasoactive and inflammatory mediator and cfDNA levels in the blood samples pre-OP, during OP (30 and 60 minutes after start CPB and end of CPB) and 24 hours after surgery (for the first 2x25 patients)<br>3) SOFA subscores (delta mean SOFA subscores pre-OP until day 9 post-OP)<br>4) Incidence of stroke within 30 days after surgery<br>5) Number of days on ventilator, vasopressor and renal replacement therapy within 30 days after surgery<br>6) Length of in hospital and ICU stay<br>