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Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

This study is currently recruiting participants.
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
History of Changes

August 6, 2010
January 25, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01178359 on ClinicalTrials.gov Archive Site
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Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients
Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

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.

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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Cardiac Arrest
Drug: nitrite
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michele Olsufka, RN 206-521-1588
United States
 
NCT01178359
35739-B
Yes
Francis Kim, University of Washington
University of Washington
  • Medic One Foundation
  • Institute of Translational Health Sciences (University of Washington)
Principal Investigator: Francis Kim, MD University of Washington
University of Washington
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP