Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

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 hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Diazoxide

Criteria

Inclusion Criteria:

• Age 18 years or older

• Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest

• Patient scheduled for elective cardiac surgery

Exclusion Criteria:

• 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