NCT01178359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

6.3 years

First QC Date

August 6, 2010

Last Update Submit

May 16, 2017

Conditions

Cardiac Arrest

Keywords

cardiac arrestventricular fibrillationnitrite

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    2 hour

  • nitrite concentration levels in blood

    2 hour

Interventions

nitriteDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successfully resuscitated from cardiac arrest by paramedics in the field Age 18 or older Comatose IV access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Heart ArrestVentricular Fibrillation

Interventions

Nitrites

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitrous AcidNitrogen CompoundsOrganic Chemicals

Study Officials

  • Francis Kim, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Medicine/Division of Cardiology

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 10, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

US(1)