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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05270902
Other study ID # 1933/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date June 30, 2024

Study information

Verified date March 2023
Source Medical University of Vienna
Contact Martin H. Bernardi, MD, PhD
Phone 0043140400
Email martin.bernardi@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients undergoing heart transplantation Exclusion Criteria: - Declined informed consent - Age < 18 years# - Receiving antileukocyte drugs - Receiving TNF-a Blockers, immunosuppressive drugs (e.g. tocilizumab) - DCD - Ex-vivo perfusion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CytoSorb Adsorber
Polymer based adsorber system for the elimination of cytokines

Locations

Country Name City State
Austria Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in maximal cytokine peak levels (IL-1ß, IL-6, IL-33, TNF-a, IL-10) Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA 5 days
Secondary Difference of immunosuppression (TTV) Individual immunosuppression measured by Torque-teno-virus load 30days
Secondary Difference of immunosuppression (sST2) Individual immunosuppression measured by sST2 levels 30days
Secondary primary graft dysfunction score Differences in primary graft dysfunction score between both groups 7 days
Secondary 30-day mortality Differences in 30-day mortality between both groups 30 days
Secondary Mechanical Ventilation Differences in length of mechanical ventilation up to 4 weeks
Secondary Delirium Differences in Confusion assessment method for the ICU between both groups 5 days
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