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Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest (SNOCAT)

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ClinicalTrials.gov Identifier: NCT03452917
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : December 29, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Francis Kim, University of Washington

Brief Summary:
In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Drug: Placebo Drug: sodium nitrite 45 mg Drug: sodium nitrite 60 mg Phase 2 Phase 3

Detailed Description:

The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.

Patients will be eligible for this study if:

  1. Intravenous access (IV)/intraosseous access(IO)
  2. Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
  3. Age 18 years or older
  4. Comatose

Exclusion Criteria

  1. Traumatic cause of cardiac arrest
  2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
  3. Known DNAR
  4. Drowning as cause of arrest.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
2 ml of normal saline (n=500)
Drug: Placebo
500 patients will 2 ml of normal saline

Experimental: sodium nitrite
45 mg IV of sodium nitrite (n=500) or 60 mg IV sodium nitrite (n=500) given during active resuscitation from out of hospital cardiac arrest.
Drug: sodium nitrite 45 mg
500 patients will receive 45 mg IV sodium nitrite

Drug: sodium nitrite 60 mg
500 patients will receive a dose of 60 mg IV sodium nitrite




Primary Outcome Measures :
  1. Survival to hospital admission [ Time Frame: within 24 hours after out of hospital cardiac arrest ]
    Patient has sustained pulse at arrival to the emergency department


Secondary Outcome Measures :
  1. Survival to discharge [ Time Frame: within 3-6 months after cardiac arrest ]
    Patient alive at time of discharge from hospital

  2. Number of days in ICU [ Time Frame: Within first 3 months of hospital admission ]
    Number of days the patient is admitted to the Intensive Care Unit

  3. survival to 24 hours [ Time Frame: within first 24 h after hospital admission ]
    Patient is alive after the first 24 hours after admission to the hospital

  4. Re-arrest or use of pressers in field by paramedics [ Time Frame: before hospital arrival ]
    Patient loses pulses and or required use of pressers in the field

  5. Survival to 48 hours after admission to hospital [ Time Frame: within first 48 hours after admission to hospital ]
    Patient is alive after first 48 hours after admission to the hospital

  6. Survival to 72 hours after admission to hospital [ Time Frame: within first 72 hours after admission to hospital ]
    Patient is alive after first 72 hours after admission to the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
  • IV or IO access
  • Comatose

Exclusion Criteria:

  • traumatic cause of cardiac arrest
  • prisoner, pregnancy
  • known DNAR

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452917


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Francis Kim, MD University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francis Kim, Professor, Medicine/Division of Cardiology, University of Washington
ClinicalTrials.gov Identifier: NCT03452917    
Other Study ID Numbers: 51605
R01HL129722 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases