Cytosorb Therapy in Cardiac Surgery

Endocarditis Clinical Trial

Official title:

Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309591
• Other study ID #: 2019-01740; ch19Santer
• Status: Completed
• Start date: October 18, 2019
• Est. completion date: December 4, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• denial of consent for data use

Related Conditions & MeSH terms

• Cardiopulmonary Surgery
• Endocarditis
• Peri-operative Cytokines Levels

Intervention

Device:
• CytoSorb haemoadsorption (HA) device
CytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery .

Locations

Country	Name	City	State
Switzerland	Klinik für Herzchirurgie, Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital mortality	In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption	during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
Secondary	time in intensive care unit (days)	time in intensive care unit (days)	during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
Secondary	In-Hospital time (days)	In-Hospital time (days)	hospital stay for cardiac surgery from admission until discharge (approximately 15 days)