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Completed

NCT Number: NCT06308107

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

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.

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Key information

Conditions

Myocardial Stunning Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Diazoxide

Drug

500 micromoles added to one liter of cardioplegia

Primary outcomes

  1. Safety as assessed by mean change in blood pressure

    Time frame: From first dose of cardioplegia through 24 hours post operatively

    Mean blood pressure measurements in mmHg.

  2. Safety as assessed by change in blood glucose levels

    Time frame: From first dose of cardioplegia through 48 hours post operatively

    Blood glucose levels in mg/dl.

  3. Safety as assessed by incidence of adverse events

    Time frame: From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first

    Safety will be assessed by total number of adverse events.

Secondary outcomes

  1. Efficacy as assessed by change in ejection fraction

    Time frame: Day of surgery (pre and post surgery)

    Comparison of right and left ventricular function (measured as a percentage) on pre and post operative Transesophageal echocardiograms

  2. Efficacy as assessed by use of mechanical circulatory support

    Time frame: 48 hours post operatively

    Incidence of mechanical circulatory support use will be used in the assessment of efficacy.

  3. Efficacy as assessed by change in Vasoactive Inotropic Score (VIS)

    Time frame: 0, 24, 48 and 72 hours post operatively

    Comparison of VIS Score with values from 0 to >45, with lower scores indicating medication efficacy (0e5, >5e15, >15e30, >30e45, and >45 points).

  4. Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB)

    Time frame: Day of surgery

    From time of first turn down of CPB to CPB end time measured in minutes.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Magic That Matters

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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