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Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB

NCT03104179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-07

No results posted yet for this study

Summary

In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.

They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.

Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.

These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.

There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.

Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.

Conditions

  • Extracorporeal Circulation
  • Hemofiltration

Interventions

DEVICE

Cytosorb Adsorber

Cytokine adsorption during CPB

Sponsors & Collaborators

  • CytoSorbents, Inc

    collaborator INDUSTRY

  • Klinikum Nürnberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104179 on ClinicalTrials.gov