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

NCT ID: NCT04830982

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-10-30

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 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.

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). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.

Conditions

Myocardial Stunning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Diazoxide

IV Diazoxide as additive to hypothermic hyperkalemic cardioplegia.

Group Type: EXPERIMENTAL

IV Diazoxide

Intervention Type: DRUG

500 micromoles added to one liter of cardioplegia

Placebo

Placebo as additive to hypothermic hyperkalemic cardioplegia.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo added to one liter of cardioplegia

Interventions

IV Diazoxide

500 micromoles added to one liter of cardioplegia

Intervention Type: DRUG

Placebo

Placebo added to one liter of cardioplegia

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Lawton, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00265542

Identifier Type: -

Identifier Source: org_study_id