Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2010 |
| End Date: | March 2016 |
| Contact: | Michele Olsufka, RN |
| Phone: | 206-521-1588 |
Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
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.
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
(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
Inclusion Criteria:
- Successfully resuscitated from cardiac arrest by paramedics in the field Age 18 or
older Comatose IV access
Exclusion Criteria:
- traumatic cause of cardiac arrest known DNAR Patient requiring vasopressors at time
of randomization SBP <105 PaO2 of less than 90% on FiO2 of 1.0
We found this trial at
1
site
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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