Trial · NCT03452917

Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

NCT03452917, Phase 2, Phase 3, Completed, University of Washington; results first posted 2023-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest. Trials, record NCT03452917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03452917

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
NCT number: NCT03452917
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,502 participants, actual
Lead sponsor: University of Washington
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: Placebo, sodium nitrite 45 mg, sodium nitrite 60 mg
First posted: 2018-03-02
Last updated: 2023-05-24
Results first posted: 2023-05-24

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Survived to Hospital Admission	within 24 hours after out of hospital cardiac arrest	Patient has sustained pulse at arrival to the emergency department
Secondary	Survival to Discharge	within 3-6 months after cardiac arrest	Patient alive at time of discharge from hospital
Secondary	Number of Days in ICU	Within first 3 months of hospital admission	Number of days the patient is admitted to the Intensive Care Unit
Secondary	Survival to 24 Hours	within first 24 h after hospital admission	Patient is alive after the first 24 hours after admission to the hospital
Secondary	Re-arrest	before hospital arrival	Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.
Secondary	Survival to 48 Hours After Admission to Hospital	within first 48 hours after admission to hospital	Patient is alive after first 48 hours after admission to the hospital
Secondary	Survival to 72 Hours After Admission to Hospital	within first 72 hours after admission to hospital	Patient is alive after first 72 hours after admission to the hospital

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants Who Survived to Hospital Admission	within 24 hours after out of hospital cardiac arrest	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival to Discharge	within 3-6 months after cardiac arrest	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Days in ICU	Within first 3 months of hospital admission	days	MEAN
SECONDARY	Survival to 24 Hours	within first 24 h after hospital admission	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Re-arrest	before hospital arrival	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival to 48 Hours After Admission to Hospital	within first 48 hours after admission to hospital	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival to 72 Hours After Admission to Hospital	within first 72 hours after admission to hospital	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants Who Survived to Hospital Admission	Placebo	218		Participants
Number of Participants Who Survived to Hospital Admission	Sodium Nitrite 45 mg	205		Participants
Number of Participants Who Survived to Hospital Admission	Sodium Nitrite 60 mg	212		Participants
Survival to Discharge	Placebo	74		Participants
Survival to Discharge	Sodium Nitrite 45 mg	66		Participants
Survival to Discharge	Sodium Nitrite 60 mg	72		Participants
Number of Days in ICU	Placebo	6.7	Standard Deviation 8.1	days
Number of Days in ICU	Sodium Nitrite 45 mg	8.9	Standard Deviation 10.4	days
Number of Days in ICU	Sodium Nitrite 60 mg	7.3	Standard Deviation 7.2	days
Survival to 24 Hours	Placebo	181		Participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	499
Overall Study	STARTED	Sodium Nitrite 45 mg	500
Overall Study	STARTED	Sodium Nitrite 60 mg	498
Overall Study	COMPLETED	Placebo	499
Overall Study	COMPLETED	Sodium Nitrite 45 mg	500
Overall Study	COMPLETED	Sodium Nitrite 60 mg	498
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Sodium Nitrite 45 mg	0
Overall Study	NOT COMPLETED	Sodium Nitrite 60 mg	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Positive troponin	Cardiac disorders	Placebo	21	496	21
other	Positive troponin	Cardiac disorders	Sodium Nitrite 45 mg	19	499	19
other	Positive troponin	Cardiac disorders	Sodium Nitrite 60 mg	15	497	15
serious	Re-arrest first 24 hours of hospitalization	Cardiac disorders	Placebo	76	496	76
serious	Re-arrest first 24 hours of hospitalization	Cardiac disorders	Sodium Nitrite 45 mg	65	499	65
serious	Re-arrest first 24 hours of hospitalization	Cardiac disorders	Sodium Nitrite 60 mg	74	497	74
serious	Pressors in first 24 hours after hospitalization	Cardiac disorders	Placebo	190	496	190
serious	Pressors in first 24 hours after hospitalization	Cardiac disorders	Sodium Nitrite 45 mg	173	499	173
serious	Pressors in first 24 hours after hospitalization	Cardiac disorders	Sodium Nitrite 60 mg	185	497	185
serious	sustained hypotension in hospital, first 24 hours	Cardiac disorders	Placebo	14	496	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	422	496
Total, all-cause mortality	Sodium Nitrite 45 mg	433	499
Total, all-cause mortality	Sodium Nitrite 60 mg	425	497
Total, other adverse events	Placebo	21	496
Total, other adverse events	Sodium Nitrite 45 mg	19	499
Total, other adverse events	Sodium Nitrite 60 mg	15	497
Total, serious adverse events	Placebo	280	496
Total, serious adverse events	Sodium Nitrite 45 mg	249	499
Total, serious adverse events	Sodium Nitrite 60 mg	268	497

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33433575	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL129722	Randomized clinical trial of sodium nitrite for out of hospital cardiac arrest	KIM, FRANCIS	UNIVERSITY OF WASHINGTON	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2016 to 2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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