Cytosorb Therapy in Cardiac Surgery

NCT ID: NCT04309591

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-18

Study Completion Date

2019-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiopulmonary Surgery Endocarditis Peri-operative Cytokines Levels

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 .

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* denial of consent for data use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Santer, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel, Herzchirurgie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinik für Herzchirurgie, Universitätsspital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-01740; ch19Santer

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cryoanalgesia Study
NCT05859061 COMPLETED NA