Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Arrest |
Drug: nitrite |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients |
- Blood pressure [ Time Frame: 2 hour ] [ Designated as safety issue: Yes ]
- nitrite concentration levels in blood [ Time Frame: 2 hour ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01178359
| Contact: Michele Olsufka, RN | 206-521-1588 |
| United States, Washington | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Francis Kim, MD | University of Washington |
More Information
No publications provided
| Responsible Party: | Francis Kim, Study Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01178359 History of Changes |
| Other Study ID Numbers: | 35739-B |
| Study First Received: | August 6, 2010 |
| Last Updated: | November 21, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Washington:
|
cardiac arrest ventricular fibrillation nitrite |
Additional relevant MeSH terms:
|
Heart Arrest Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on March 03, 2015