Cytosorb Therapy in Cardiac Surgery

March 12, 2020 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Klinik für Herzchirurgie, Universitätsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit at the University Hospital Basel

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • denial of consent for data use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Hospital mortality
Time Frame: 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
during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time in intensive care unit (days)
Time Frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
time in intensive care unit (days)
during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
In-Hospital time (days)
Time Frame: hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
In-Hospital time (days)
hospital stay for cardiac surgery from admission until discharge (approximately 15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: David Santer, Dr. med, Universitätsspital Basel, Herzchirurgie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

December 4, 2019

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01740; ch19Santer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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