Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

This study has been completed.

Sponsor:

Collaborator:

Medic One Foundation

Information provided by (Responsible Party):

Francis Kim, University of Washington

ClinicalTrials.gov Identifier:

NCT01178359

First received: August 6, 2010

Last updated: May 11, 2016

Last verified: May 2016

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest

Genetic and Rare Diseases Information Center resources: Paroxysmal Ventricular Fibrillation

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

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 ]


Enrollment:	11
Study Start Date:	January 2010
Study Completion Date:	April 2016
Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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:	May 11, 2016
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 Heart Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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