Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
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ClinicalTrials.gov Identifier: NCT01178359 |
Recruitment Status :
Completed
First Posted : August 10, 2010
Last Update Posted : May 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiac Arrest | Drug: nitrite | Phase 1 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

- Blood pressure [ Time Frame: 2 hour ]
- nitrite concentration levels in blood [ Time Frame: 2 hour ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178359
United States, Washington | |
Harborview Medical Center | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Francis Kim, MD | University of Washington |
Responsible Party: | Francis Kim, Associate Professor, Medicine/Division of Cardiology, University of Washington |
ClinicalTrials.gov Identifier: | NCT01178359 |
Other Study ID Numbers: |
STUDY00001499 |
First Posted: | August 10, 2010 Key Record Dates |
Last Update Posted: | May 18, 2017 |
Last Verified: | May 2017 |
cardiac arrest ventricular fibrillation nitrite |
Heart Arrest Heart Diseases Cardiovascular Diseases |