Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

• ClinicalTrials.gov Identifier: NCT01178359
• Recruitment Status: Completed
• First Posted: August 10, 2010
• Last Update Posted: May 18, 2017
• Sponsor: University of Washington
• Collaborator: Medic One Foundation
• Information provided by (Responsible Party): Francis Kim, University of Washington

Study Description

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

• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

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

• 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
• 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