Cytosorb Therapy in Cardiac Surgery

Completed

• Conditions: Cardiopulmonary Surgery; Endocarditis; Peri-operative Cytokines Levels

• Registration Number: NCT04309591
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-18
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit

Exclusion Criteria

• denial of consent for data use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-Hospital mortality	during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)	In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption

Secondary Outcome Measures

Name	Time	Method
time in intensive care unit (days)	during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)	time in intensive care unit (days)
In-Hospital time (days)	hospital stay for cardiac surgery from admission until discharge (approximately 15 days)	In-Hospital time (days)

Trial Locations

Locations (1)

Klinik für Herzchirurgie, Universitätsspital Basel; 🇨🇭 Basel, Switzerland