Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial

Johns Hopkins University

Status and phase

Completed

Phase 1

Conditions

Myocardial Stunning

Treatments

Drug: IV Diazoxide

Study type

Interventional

Funder types

Other

Identifiers

NCT06308107

IRB00433127

Details and patient eligibility

About

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. Thirty patients will receive treatment. 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.

Full description

This is a Phase I clinical trial. Thirty patients total will receive treatment (IV Diazoxide added to cardioplegia). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older
Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
Patient scheduled for elective cardiac surgery
If female participant of childbearing potential, she must agree to and be able to use a highly effective method of birth control (eg, barrier contraceptives, hormonal contraceptives, intrauterine devices, or sexual abstinence) continuously for six days post- diazoxide dose

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
Patients with seizure disorders controlled by diphenylhydantoin
Patients with a history of cold agglutinins