Status:
WITHDRAWN
Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Lead Sponsor:
Johns Hopkins University
Conditions:
Myocardial Stunning
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypoth...
Detailed Description
This is a randomized blinded Phase I clinical trial. Thirty patients total will be randomized on a 2:1 basis to treatment (IV Diazoxide added to cardioplegia) vs control (cardioplegia alone). Diazoxid...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
- Patient scheduled for elective cardiac surgery
Exclusion
- Patient with Diabetes Mellitus on sulfonylurea medications
- Scheduled for left ventricular assist device (LVAD) or heart transplant
- Left ventricular ejection fraction \< 30%
- Pre-operative placement or planned use of mechanical circulatory support during surgery
- Allergy to Thiazide and its derivatives
- History of gout
- Patient is pregnant or breastfeeding
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04830982
Start Date
September 1 2023
End Date
October 30 2025
Last Update
September 19 2022
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287