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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06308107
Other study ID # IRB00433127
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date July 1, 2024
Est. completion date April 30, 2028

Study information

Verified date June 2024
Source Johns Hopkins University
Contact Lisa Fornaresio, PhD
Phone 443.927.3984
Email lisa.fornaresio@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 30, 2028
Est. primary completion date April 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IV Diazoxide
500 micromoles added to one liter of cardioplegia

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Magic That Matters

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as assessed by mean change in blood pressure Mean blood pressure measurements in mmHg. From first dose of cardioplegia through 24 hours post operatively
Primary Safety as assessed by change in blood glucose levels Blood glucose levels in mg/dl. From first dose of cardioplegia through 48 hours post operatively
Primary Safety as assessed by incidence of adverse events Safety will be assessed by total number of adverse events. From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first
Secondary Efficacy as assessed by change in ejection fraction Comparison of right and left ventricular function (measured as a percentage) on pre and post operative Transesophageal echocardiograms Day of surgery (pre and post surgery)
Secondary Efficacy as assessed by use of mechanical circulatory support Incidence of mechanical circulatory support use will be used in the assessment of efficacy. 48 hours post operatively
Secondary Efficacy as assessed by change in Vasoactive Inotropic Score (VIS) Comparison of VIS Score with values from 0 to >45, with lower scores indicating medication efficacy (0e5, >5e15, >15e30, >30e45, and >45 points). 0, 24, 48 and 72 hours post operatively
Secondary Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB) From time of first turn down of CPB to CPB end time measured in minutes. Day of surgery
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