Trial Outcomes & Findings for Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest (NCT NCT03079102)
NCT ID: NCT03079102
Last Updated: 2022-04-25
Results Overview
Composite of in-hospital death; OR unfavorable discharge location defined as a skilled nursing facility (SNF), long term acute care (LTAC) or hospice; OR New York Heart Association (NYHA) class III/IV heart failure at the time of discharge.\* \*In the setting of pre-existing heart failure there must be at least a 1 class decrement (eg III -\> IV). If patient was previously housed in a "unfavorable" destination there must be a 1 point decrement (eg from SNF to LTAC or LTAC to hospice). Subjects with pre-existing NYHA IV symptoms or living in hospice are excluded from meeting the respective outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Hospital discharge (+/- 3 days)
Results posted on
2022-04-25
Participant Flow
All patients were enrolled in the emergency room or intensive care unit. Screening for this study began on 8/21/2017. First enrollment was 8/26/2017 and the final enrollment was 4/25/2020.
Patients were assigned at the time of enrollment since enrollment was under exception from informed consent and all assigned patients were started on study drug.
Participant milestones
| Measure |
Inhaled Nitric Oxide (iNO)
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
|
Overall Study
COMPLETED
|
30
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Inhaled Nitric Oxide (iNO)
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
60 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Height
|
171.5 centimeters
n=5 Participants
|
167.8 centimeters
n=7 Participants
|
170 centimeters
n=5 Participants
|
|
Weight
|
86.6 kilograms
n=5 Participants
|
81.7 kilograms
n=7 Participants
|
85 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Hospital discharge (+/- 3 days)Population: All patients enrolled were followed to primary outcome consistent with FDA policies for trials conducted under exception from informed consent
Composite of in-hospital death; OR unfavorable discharge location defined as a skilled nursing facility (SNF), long term acute care (LTAC) or hospice; OR New York Heart Association (NYHA) class III/IV heart failure at the time of discharge.\* \*In the setting of pre-existing heart failure there must be at least a 1 class decrement (eg III -\> IV). If patient was previously housed in a "unfavorable" destination there must be a 1 point decrement (eg from SNF to LTAC or LTAC to hospice). Subjects with pre-existing NYHA IV symptoms or living in hospice are excluded from meeting the respective outcome.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Participants With Death or Significant Neurological or Cardiac Impairment
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (+/- 3 days)Patient declared dead at designated time point
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects Dead
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 days after cardiac arrest (+/- 3 days)Patient declared dead at designated time point
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=28 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects Dead
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 90 days after cardiac arrest (+/- 3 days)Patient declared dead at designated time point
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=27 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=25 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects Dead
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (+/- 3 days)The cerebral performance category (CPC) is a standardized scale from 1-5 describing neurological and functional outcome with a long history of use in cardiac arrest trials (N Engl J Med 1986; 314:397-403). Lower scores indicate better neurological performance as follows: (1) conscious and alert with normal function or only slight disability, (2) conscious and alert with moderate disability, (3) conscious with severe disability, (4) comatose or in a persistent vegetative state, or (5) dead. CPC will be dichotomized as favorable (1, 2) or unfavorable (3-5) at designated time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Cerebral Performance Category (CPC)
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 days after cardiac arrest (+/- 3 days)The cerebral performance category (CPC) is a standardized scale from 1-5 describing neurological and functional outcome with a long history of use in cardiac arrest trials (N Engl J Med 1986; 314:397-403). Lower scores indicate better neurological performance as follows: (1) conscious and alert with normal function or only slight disability, (2) conscious and alert with moderate disability, (3) conscious with severe disability, (4) comatose or in a persistent vegetative state, or (5) dead. CPC will be dichotomized as favorable (1, 2) or unfavorable (3-5) at designated time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=27 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=26 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Cerebral Performance Category (CPC)
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 days after cardiac arrest (+/- 3 days)The cerebral performance category (CPC) is a standardized scale from 1-5 describing neurological and functional outcome with a long history of use in cardiac arrest trials (N Engl J Med 1986; 314:397-403). Lower scores indicate better neurological performance as follows: (1) conscious and alert with normal function or only slight disability, (2) conscious and alert with moderate disability, (3) conscious with severe disability, (4) comatose or in a persistent vegetative state, or (5) dead. CPC will be dichotomized as favorable (1, 2) or unfavorable (3-5) at designated time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=27 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Cerebral Performance Category (CPC)
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (+/- 3 days)The modified Rankin Score (mRS) is now recommended by consensus as the best measure of neurologic outcome in cardiac arrest studies (Circulation. 2018;137:e783-e801). The mRS runs from 0-6, where higher numbers are consistent with more severe neurologic impairment up to death (6). The scores correspond to: (0) No symptoms; (1) No significant disability. Able to carry out all usual activities, despite some symptoms.;(2) Slight disability; (3) Moderate disability; (4) Moderately severe disability; (5) Severe disability; (6) Dead. This score was dichotomized as favorable (0-3) or unfavorable (4-6) at the appointed time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Modified Rankin Score (mRS)
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 days after cardiac arrest (+/- 3 days)The modified Rankin Score (mRS) is now recommended by consensus as the best measure of neurologic outcome in cardiac arrest studies (Circulation. 2018;137:e783-e801). The mRS runs from 0-6, where higher numbers are consistent with more severe neurologic impairment up to death (6). The scores correspond to: (0) No symptoms; (1) No significant disability. Able to carry out all usual activities, despite some symptoms.;(2) Slight disability; (3) Moderate disability; (4) Moderately severe disability; (5) Severe disability; (6) Dead. This score was dichotomized as favorable (0-3) or unfavorable (4-6) at the appointed time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=27 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=26 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Modified Rankin Score (mRS)
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 90 days after cardiac arrest (+/- 3 days)The modified Rankin Score (mRS) is now recommended by consensus as the best measure of neurologic outcome in cardiac arrest studies (Circulation. 2018;137:e783-e801). The mRS runs from 0-6, where higher numbers are consistent with more severe neurologic impairment up to death (6). The scores correspond to: (0) No symptoms; (1) No significant disability. Able to carry out all usual activities, despite some symptoms.;(2) Slight disability; (3) Moderate disability; (4) Moderately severe disability; (5) Severe disability; (6) Dead. This score was dichotomized as favorable (0-3) or unfavorable (4-6) at the appointed time.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=27 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=23 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects With a Favorable Modified Rankin Score (mRS)
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (+/- 3 days)Favorable discharge destination was defined as discharge from the hospital to home or inpatient rehabilitation. Unfavorable discharge destination was defined as discharge to a skilled nursing facility, long term acute care facility, hospice or death.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Number of Subjects Discharged to a Favorable Destination
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (+/- 3 days)Population: One surviving subject in placebo group withdrew consent before discharge and was therefore not assessed.
Barthel Index of Independence in Activities of Daily Living scored as a continuous 0-100 at designated time. A higher score indicates improved ability to independently perform the activities of daily living.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=17 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=15 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Barthel Index (Activities of Daily Living)
|
70 score on a scale
Interval 30.0 to 100.0
|
65 score on a scale
Interval 5.0 to 90.0
|
SECONDARY outcome
Timeframe: 30 days after cardiac arrest (+/- 3 days)Barthel Index of Independence in Activities of Daily Living scored as a continuous 0-100 at designated time. A higher score indicates improved ability to independently perform the activities of daily living.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=12 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=14 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Barthel Index (Activities of Daily Living)
|
100 score on a scale
Interval 48.7 to 100.0
|
95 score on a scale
Interval 3.75 to 100.0
|
SECONDARY outcome
Timeframe: 90 days after cardiac arrest (+/- 3 days)Barthel Index of Independence in Activities of Daily Living scored as a continuous 0-100 at designated time. A higher score indicates improved ability to independently perform the activities of daily living.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=11 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=11 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Barthel Index (Activities of Daily Living)
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Within 4 days of cardiac arrestTime in hours until subject is noted to follow commands. Subjects exceeding 96 hours of coma and those that die without awakening will be designated as 100.
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=8 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=5 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Time to Awakening
|
47.5 hours
Interval 25.0 to 100.0
|
25 hours
Interval 17.0 to 26.0
|
SECONDARY outcome
Timeframe: Prior to study drugMethemoglobin content as proportion (%) of total hemoglobin
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=6 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=4 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Methemoglobin Level
|
0.1 percentage of hemoglobin
Interval 0.0 to 0.625
|
0.2 percentage of hemoglobin
Interval 0.1 to 0.4
|
SECONDARY outcome
Timeframe: 6 hours after study drug initiatedMethemoglobin content as proportion (%) of total hemoglobin
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=17 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=14 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Methemoglobin Level
|
1.1 percentage of hemoglobin
Interval 0.8 to 1.2
|
0.5 percentage of hemoglobin
Interval 0.4 to 0.6
|
SECONDARY outcome
Timeframe: 12 hours after study drug initiatedMethemoglobin content as proportion (%) of total hemoglobin
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=6 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=6 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Methemoglobin Level
|
0.8 percentage of hemoglobin
Interval 0.275 to 0.875
|
0.3 percentage of hemoglobin
Interval 0.125 to 0.55
|
SECONDARY outcome
Timeframe: Hourly from 0 - 12 hours of study drugPopulation: Missing values occurred due to death during study drug (iNO, 2; placebo, 1), withdrawal of consent (iNO, 1; placebo, 1), termination of study by PI and subsequent death (placebo, 1), procedures outside the ICU (placebo, 1), arterial line delay or malfunction (iNO, 1; placebo, 2).
Measured by arterial line
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=29 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=26 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Diastolic Blood Pressure
Time zero (immediately before study drug)
|
75.1 mm Hg
Standard Deviation 2.8
|
67.3 mm Hg
Standard Deviation 3.7
|
|
Diastolic Blood Pressure
1 hour after study drug
|
72.5 mm Hg
Standard Deviation 4.6
|
67.3 mm Hg
Standard Deviation 2.2
|
|
Diastolic Blood Pressure
2 hours after study drug
|
72.1 mm Hg
Standard Deviation 3.3
|
67.0 mm Hg
Standard Deviation 4.2
|
|
Diastolic Blood Pressure
3 hours after study drug
|
71.3 mm Hg
Standard Deviation 2.7
|
67.0 mm Hg
Standard Deviation 2.3
|
|
Diastolic Blood Pressure
4 hours after study drug
|
71.6 mm Hg
Standard Deviation 2.4
|
68.1 mm Hg
Standard Deviation 3.6
|
|
Diastolic Blood Pressure
5 hours after study drug
|
72.6 mm Hg
Standard Deviation 3.7
|
62.9 mm Hg
Standard Deviation 2.2
|
|
Diastolic Blood Pressure
6 hours after study drug
|
74.9 mm Hg
Standard Deviation 2.7
|
67.8 mm Hg
Standard Deviation 3.1
|
|
Diastolic Blood Pressure
7 hours after study drug
|
68.7 mm Hg
Standard Deviation 3.8
|
66.5 mm Hg
Standard Deviation 4.1
|
|
Diastolic Blood Pressure
8 hours after study drug
|
71.5 mm Hg
Standard Deviation 2.4
|
65.5 mm Hg
Standard Deviation 3.5
|
|
Diastolic Blood Pressure
9 hours after study drug
|
70.8 mm Hg
Standard Deviation 3.3
|
62.9 mm Hg
Standard Deviation 2.3
|
|
Diastolic Blood Pressure
10 hours after study drug
|
71.4 mm Hg
Standard Deviation 2.3
|
66.4 mm Hg
Standard Deviation 3.7
|
|
Diastolic Blood Pressure
11 hours after study drug
|
70.7 mm Hg
Standard Deviation 2.9
|
61.5 mm Hg
Standard Deviation 2.0
|
|
Diastolic Blood Pressure
12 hours after study drug
|
67.0 mm Hg
Standard Deviation 2.3
|
66.6 mm Hg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Hourly from 0 - 12 hours of study drugPopulation: Missing values occurred due to death during study drug (iNO, 2; placebo, 1), withdrawal of consent (iNO, 1; placebo, 1), termination of study by PI and subsequent death (placebo, 1), procedures outside the ICU (placebo, 1), arterial line delay or malfunction (iNO, 1; placebo, 2).
Measured by arterial line
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=29 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=26 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Systolic Blood Pressure
0 hour (immediately before study drug start)
|
143.1 mm Hg
Standard Deviation 6.6
|
140.0 mm Hg
Standard Deviation 7.6
|
|
Systolic Blood Pressure
1 hour after study drug
|
141.1 mm Hg
Standard Deviation 6.6
|
136.1 mm Hg
Standard Deviation 7.3
|
|
Systolic Blood Pressure
2 hours after study drug
|
132.2 mm Hg
Standard Deviation 5.2
|
140.5 mm Hg
Standard Deviation 6.5
|
|
Systolic Blood Pressure
3 hours after study drug
|
138.9 mm Hg
Standard Deviation 5.3
|
132.5 mm Hg
Standard Deviation 5.8
|
|
Systolic Blood Pressure
4 hours after study drug
|
135.3 mm Hg
Standard Deviation 4.5
|
134.3 mm Hg
Standard Deviation 5.3
|
|
Systolic Blood Pressure
5 hours after study drug
|
131.4 mm Hg
Standard Deviation 3.9
|
134. mm Hg
Standard Deviation 5.3
|
|
Systolic Blood Pressure
6 hours after study drug
|
126.2 mm Hg
Standard Deviation 4.0
|
139.8 mm Hg
Standard Deviation 5.9
|
|
Systolic Blood Pressure
7 hours after study drug
|
129.0 mm Hg
Standard Deviation 3.8
|
128.8 mm Hg
Standard Deviation 6.1
|
|
Systolic Blood Pressure
8 hours after study drug
|
126.0 mm Hg
Standard Deviation 4.0
|
132.2 mm Hg
Standard Deviation 6.0
|
|
Systolic Blood Pressure
9 hours after study drug
|
125.9 mm Hg
Standard Deviation 3.9
|
132.5 mm Hg
Standard Deviation 6.2
|
|
Systolic Blood Pressure
10 hours after study drug
|
127.1 mm Hg
Standard Deviation 3.8
|
136.8 mm Hg
Standard Deviation 5.9
|
|
Systolic Blood Pressure
11 hours after study drug
|
119.4 mm Hg
Standard Deviation 3.7
|
136.7 mm Hg
Standard Deviation 5.0
|
|
Systolic Blood Pressure
12 hours after study drug
|
119.4 mm Hg
Standard Deviation 3.7
|
134.2 mm Hg
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Hourly from 0 - 12 hours of study drugPopulation: Missing values occurred due to death during study drug (iNO, 2; placebo, 1), withdrawal of consent (iNO, 1; placebo, 1), termination of study by PI (placebo, 1), procedures outside the ICU (placebo, 1).
Calculated from continuous telemetry by monitor
Outcome measures
| Measure |
Inhaled Nitric Oxide (iNO)
n=29 Participants
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=26 Participants
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Heart Rate
0 hour (immediately before study drug)
|
90.0 beats per minute
Standard Deviation 3.8
|
31.1 beats per minute
Standard Deviation 3.4
|
|
Heart Rate
1 hour after study drug start
|
85.2 beats per minute
Standard Deviation 3.6
|
91.8 beats per minute
Standard Deviation 5.5
|
|
Heart Rate
2 hours after study drug start
|
84.4 beats per minute
Standard Deviation 3.2
|
85.7 beats per minute
Standard Deviation 4.5
|
|
Heart Rate
3 hours after study drug start
|
82.3 beats per minute
Standard Deviation 3.3
|
85.9 beats per minute
Standard Deviation 4.6
|
|
Heart Rate
4 hours after study drug start
|
77.1 beats per minute
Standard Deviation 3.0
|
83.6 beats per minute
Standard Deviation 4.3
|
|
Heart Rate
5 hours after study drug start
|
78.0 beats per minute
Standard Deviation 2.9
|
79.8 beats per minute
Standard Deviation 4.2
|
|
Heart Rate
6 hours after study drug start
|
76.7 beats per minute
Standard Deviation 3.1
|
77.5 beats per minute
Standard Deviation 4.0
|
|
Heart Rate
7 hours after study drug start
|
76.8 beats per minute
Standard Deviation 3.3
|
74.9 beats per minute
Standard Deviation 3.5
|
|
Heart Rate
8 hours after study drug start
|
76.1 beats per minute
Standard Deviation 3.9
|
76.0 beats per minute
Standard Deviation 3.6
|
|
Heart Rate
9 hours after study drug start
|
75.9 beats per minute
Standard Deviation 4.0
|
75.0 beats per minute
Standard Deviation 3.9
|
|
Heart Rate
10 hours after study drug start
|
74.7 beats per minute
Standard Deviation 3.9
|
75.4 beats per minute
Standard Deviation 3.2
|
|
Heart Rate
11 hours after study drug start
|
72.9 beats per minute
Standard Deviation 3.8
|
75.7 beats per minute
Standard Deviation 3.5
|
|
Heart Rate
12 hours after study drug start
|
73.4 beats per minute
Standard Deviation 3.5
|
75.9 beats per minute
Standard Deviation 4.1
|
Adverse Events
Inhaled Nitric Oxide (iNO)
Serious events: 24 serious events
Other events: 0 other events
Deaths: 14 deaths
Placebo
Serious events: 25 serious events
Other events: 0 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Inhaled Nitric Oxide (iNO)
n=30 participants at risk
20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.
Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
|
Placebo
n=27 participants at risk
Nitrogen carrier gas delivered by identical system with similar dose/taper.
Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
33.3%
10/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
37.0%
10/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
46.7%
14/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
63.0%
17/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
66.7%
20/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
88.9%
24/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
0.00%
0/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
14.8%
4/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Nervous system disorders
Cerebral edema
|
6.7%
2/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
0.00%
0/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Nervous system disorders
Stroke
|
6.7%
2/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
0.00%
0/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
|
Nervous system disorders
Myoclonic status epilepticus
|
0.00%
0/30 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
3.7%
1/27 • From start of study drug through hospital discharge, up to 90 days follow-up
Common expected serious adverse events (SAEs) are listed below and defined: * Hypotension: systolic blood pressure ≤ 90 mmHg or mean arterial blood pressure ≤65 mmHg * Hypoxia: Arterial partial pressure oxygen (paO2) \< 8 kPa (60 mmHg) when breathing room air or an oxygenation index (paO2:fraction of inspired oxygen \[FiO2\] ≤ 200 mmHg) * Metabolic acidosis: Arterial blood gas base deficit ≥ 5.0 mmol/L or serum lactate ≥ 3.6 mg/dL * Methemoglobin level \> 10%
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place