Haemoadsorption During Heart Transplantation

Not Applicable

Recruiting

• Conditions: Heart Transplantation
• Interventions: Device: CytoSorb Adsorber

• Registration Number: NCT05270902
• Lead Sponsor: Medical University of Vienna

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-26
• Study First Posted: 2022-03-08
• Study Start: 2022-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients undergoing heart transplantation

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Exclusion Criteria

• Declined informed consent
• Age < 18 years#
• Receiving antileukocyte drugs
• Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
• DCD
• Ex-vivo perfusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adsorber Group	CytoSorb Adsorber	Surgery with CPB will be performed according to institutional standards, depending on indications and surgical preferences. For the intervention group (adsorber-group), the CytoSorb adsorber will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 300-400 ml.min-1.

Primary Outcome Measures

Name	Time	Method
Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)	5 days	Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA

Secondary Outcome Measures

Name	Time	Method
Mechanical Ventilation	up to 4 weeks	Differences in length of mechanical ventilation
Difference of immunosuppression (TTV)	30days	Individual immunosuppression measured by Torque-teno-virus load
30-day mortality	30 days	Differences in 30-day mortality between both groups
Difference of immunosuppression (sST2)	30days	Individual immunosuppression measured by sST2 levels
primary graft dysfunction score	7 days	Differences in primary graft dysfunction score between both groups
Delirium	5 days	Differences in Confusion assessment method for the ICU between both groups

Trial Locations

Locations (1)

Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna; 🇦🇹 Vienna, Austria