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| Name | Class |
|---|---|
| Medic One Foundation | OTHER |
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Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than 20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac arrest and our group is eager to test this hypothesis in a clinical trial. Our overall hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will increase the proportion of patients who will survive cardiac arrest. In preparation for a clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary goal of this study.
Sixteen patients will be randomized to receive normal saline (n=5) or doses of IV nitrite (n=11). During the nitrite infusion and for 120 min after the infusion is completed, blood pressure and heart rate will be monitored.
The first 3 patients randomized to receive IV nitrite will receive the lowest dose (1 mg) of IV nitrite and compared to one placebo treated patient. If there is no significant decrease in blood pressure or elevation in heart rate, we will then dose escalate to the 6 mg dose in 4 patients and placebo in two patients. Dose escalation to the highest (14 mg) dose will again be contingent on the absence of significant hypotension or tachycardia in the drug treated patients compared to the pooled (n=3) placebo treated patients. The final block of patients will be randomized to the high nitrite dose (n=4) or placebo (n=2). Final comparisons of all groups will be made to the pooled (n=5) placebo group
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitrite | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 2 hour | |
| nitrite concentration levels in blood | 2 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Kim, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009573 | Nitrites |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D009608 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Nitrous Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |