Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Washington
Sponsor:
Collaborators:
Medic One Foundation
Institute of Translational Health Sciences (University of Washington)
Information provided by (Responsible Party):
Francis Kim, University of Washington
ClinicalTrials.gov Identifier:
NCT01178359
First received: August 6, 2010
Last updated: January 25, 2013
Last verified: January 2013
  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:


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 ]

Estimated Enrollment: 16
Study Start Date: January 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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
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

Contacts
Contact: Michele Olsufka, RN 206-521-1588

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Medic One Foundation
Institute of Translational Health Sciences (University of Washington)
Investigators
Principal Investigator: Francis Kim, MD University of Washington
  More Information

No publications provided

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: January 25, 2013
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 October 02, 2014