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| Name | Class |
|---|---|
| Magic That Matters | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diazoxide | Experimental | IV Diazoxide as additive to hypothermic hyperkalemic cardioplegia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Diazoxide | Drug | 500 micromoles added to one liter of cardioplegia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Efficacy as assessed by use of mechanical circulatory support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Lawton, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D017682 | Myocardial Stunning |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003981 | Diazoxide |
| ID | Term |
|---|---|
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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Incidence of mechanical circulatory support use will be used in the assessment of efficacy. |
| 48 hours post operatively |
| 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 |
| 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 |
| D009930 |
| Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |