Status:
COMPLETED
Jafron Haemoadsorption During Cardiopulmonary Bypass
Lead Sponsor:
Anthea Hospital Bari
Conditions:
Cytokine Release Syndrome
Eligibility:
All Genders
10-100 years
Phase:
PHASE2
Brief Summary
Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ...
Detailed Description
In this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective CPB procedures with an expected time \>120 minutes for each ext...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- elective cardiac surgery under CPB
- double valve replacement or a complex surgery with an expected CPB duration \> 120 min
- redo cardiac surgery
- Exclusion criteria:
- end-stage renal disease (dialysis dependence)
- active infectious endocarditis
- emergency or off-pump procedure
- prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days
- enrolment in another conflicting study
- administration of human albumin during CPB
Exclusion
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05349669
Start Date
May 30 2022
End Date
September 15 2022
Last Update
February 24 2023
Active Locations (1)
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1
Anthea Hospital
Bari, Apulian, Italy, 70124