Trial Outcomes & Findings for Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest (NCT NCT03452917)

NCT ID: NCT03452917

Last Updated: 2023-05-24

Results Overview

Patient has sustained pulse at arrival to the emergency department

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1502 participants
• Primary outcome timeframe: within 24 hours after out of hospital cardiac arrest
• Results posted on: 2023-05-24

Participant Flow

A total of 1502 were enrolled. A total of 1497 were randomized. 5 patients were excluded due to missing kit information.

Participant milestones

Measure	Placebo 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg sodium nitrite 60 mg (n=500)
Overall Study STARTED	499	500	498
Overall Study COMPLETED	499	500	498
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Baseline characteristics by cohort

Measure	Placebo n=496 Participants 2 ml of normal saline Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite	Sodium Nitrite 60 mg n=497 Participants 60 mg IV sodium nitrite	Total n=1492 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	222 Participants n=5 Participants	242 Participants n=7 Participants	254 Participants n=5 Participants	718 Participants n=4 Participants
Age, Categorical >=65 years	274 Participants n=5 Participants	256 Participants n=7 Participants	243 Participants n=5 Participants	773 Participants n=4 Participants
Age, Continuous	67 years n=5 Participants	65 years n=7 Participants	64 years n=5 Participants	65 years n=4 Participants
Sex: Female, Male Female	165 Participants n=5 Participants	170 Participants n=7 Participants	167 Participants n=5 Participants	502 Participants n=4 Participants
Sex: Female, Male Male	331 Participants n=5 Participants	329 Participants n=7 Participants	330 Participants n=5 Participants	990 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	186 Participants n=5 Participants	201 Participants n=7 Participants	192 Participants n=5 Participants	579 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	298 Participants n=5 Participants	284 Participants n=7 Participants	295 Participants n=5 Participants	877 Participants n=4 Participants
Race/Ethnicity, Customized White	271 Participants n=5 Participants	288 Participants n=7 Participants	273 Participants n=5 Participants	832 Participants n=4 Participants
Race/Ethnicity, Customized Black	49 Participants n=5 Participants	58 Participants n=7 Participants	51 Participants n=5 Participants	158 Participants n=4 Participants
Race/Ethnicity, Customized Asian	38 Participants n=5 Participants	39 Participants n=7 Participants	31 Participants n=5 Participants	108 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	135 Participants n=5 Participants	109 Participants n=7 Participants	140 Participants n=5 Participants	384 Participants n=4 Participants
Region of Enrollment United States	496 participants n=5 Participants	499 participants n=7 Participants	497 participants n=5 Participants	1492 participants n=4 Participants

PRIMARY outcome

Timeframe: within 24 hours after out of hospital cardiac arrest

Patient has sustained pulse at arrival to the emergency department

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Number of Participants Who Survived to Hospital Admission	218 Participants	205 Participants	212 Participants

SECONDARY outcome

Timeframe: within 3-6 months after cardiac arrest

Patient alive at time of discharge from hospital

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Survival to Discharge	74 Participants	66 Participants	72 Participants

SECONDARY outcome

Timeframe: Within first 3 months of hospital admission

Number of days the patient is admitted to the Intensive Care Unit

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Number of Days in ICU	6.7 days Standard Deviation 8.1	8.9 days Standard Deviation 10.4	7.3 days Standard Deviation 7.2

SECONDARY outcome

Timeframe: within first 24 h after hospital admission

Patient is alive after the first 24 hours after admission to the hospital

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Survival to 24 Hours	181 Participants	170 Participants	171 Participants

SECONDARY outcome

Timeframe: before hospital arrival

Patient loses pulses during transport to the hospital. Event occurs before admission to hospital.

Outcome measures

Measure	Placebo n=291 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=270 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=294 Participants sodium nitrite 60 mg (n=500)
Re-arrest	139 Participants	130 Participants	156 Participants

SECONDARY outcome

Timeframe: within first 48 hours after admission to hospital

Patient is alive after first 48 hours after admission to the hospital

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Survival to 48 Hours After Admission to Hospital	161 Participants	152 Participants	151 Participants

SECONDARY outcome

Timeframe: within first 72 hours after admission to hospital

Patient is alive after first 72 hours after admission to the hospital

Outcome measures

Measure	Placebo n=496 Participants 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 Participants 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 Participants sodium nitrite 60 mg (n=500)
Survival to 72 Hours After Admission to Hospital	142 Participants	133 Participants	131 Participants

Adverse Events

Placebo

Serious events: 280 serious events

Other events: 21 other events

Deaths: 422 deaths

Sodium Nitrite 45 mg

Serious events: 249 serious events

Other events: 19 other events

Deaths: 433 deaths

Sodium Nitrite 60 mg

Serious events: 268 serious events

Other events: 15 other events

Deaths: 425 deaths

Serious adverse events

Measure	Placebo n=496 participants at risk 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 participants at risk 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 participants at risk sodium nitrite 60 mg (n=500)
Cardiac disorders Re-arrest first 24 hours of hospitalization	15.3% 76/496 • Number of events 76 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	13.0% 65/499 • Number of events 65 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	14.9% 74/497 • Number of events 74 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.
Cardiac disorders Pressors in first 24 hours after hospitalization	38.3% 190/496 • Number of events 190 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	34.7% 173/499 • Number of events 173 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	37.2% 185/497 • Number of events 185 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.
Cardiac disorders sustained hypotension in hospital, first 24 hours	2.8% 14/496 • Number of events 14 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	2.2% 11/499 • Number of events 11 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	1.8% 9/497 • Number of events 9 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.

Other adverse events

Measure	Placebo n=496 participants at risk 2 ml of normal saline (n=500) Placebo: 500 patients will 2 ml of normal saline	Sodium Nitrite 45 mg n=499 participants at risk 45 mg IV of sodium nitrite (n=500)	Sodium Nitrite 60 mg n=497 participants at risk sodium nitrite 60 mg (n=500)
Cardiac disorders Positive troponin	4.2% 21/496 • Number of events 21 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	3.8% 19/499 • Number of events 19 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.	3.0% 15/497 • Number of events 15 • Adverse events were collected from time period of randomization to hospital discharge Other variables (rate of rearrest, use of norepinephrine in the filed) were chosen as respecified safety outcomes There were no unexpected adverse events observed in this study. Of note, this is not atypical for studies of out of hospital cardiac arrest, because it is very difficult to identify and observe adverse events for patients whose heart has stopped beating.

Additional Information

Francis Kim

University of Washington

Phone: 206-897-5264

Email: fkim@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place