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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
Sponsor:
Collaborator:
Medic One Foundation
Information provided by (Responsible Party):
Francis Kim, University of Washington

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Arrest Drug: nitrite Phase 1

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 2 hour ]
  2. nitrite concentration levels in blood [ Time Frame: 2 hour ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

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


Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Medic One Foundation
Investigators
Principal Investigator: Francis Kim, MD University of Washington
More Information
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Responsible Party: Francis Kim, Associate Professor, Medicine/Division of Cardiology, University of Washington
ClinicalTrials.gov Identifier: NCT01178359     History of Changes
Other Study ID Numbers: STUDY00001499
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Francis Kim, University of Washington:
cardiac arrest
ventricular fibrillation
nitrite

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases