Trial Outcomes & Findings for Bicarbonate in Patients With Out-of-hospital Cardiac Arrest (NCT NCT02303548)

Last Updated: 2022-03-25

Results Overview

Percentage of Participants with Return of Spontaneous Circulation (ROSC)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

checked during CPR, duration of ROSC >20 min

Results posted on

2022-03-25

Participant milestones
Measure	1 (Sodium Bicarbonate) Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes	2 (Normal Saline) Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	1 (Sodium Bicarbonate) n=25 Participants Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes	2 (Normal Saline) n=25 Participants Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo	Total n=50 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 16.4 • n=25 Participants	64.1 years STANDARD_DEVIATION 15.4 • n=25 Participants	64.8 years STANDARD_DEVIATION 16.0 • n=50 Participants
Sex: Female, Male Female	7 Participants n=25 Participants	4 Participants n=25 Participants	11 Participants n=50 Participants
Sex: Female, Male Male	18 Participants n=25 Participants	21 Participants n=25 Participants	39 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
pH	6.99 units on a scale n=25 Participants	6.90 units on a scale n=25 Participants	6.95 units on a scale n=50 Participants
Shockable pre-hospital rhythm	7 participants n=25 Participants	3 participants n=25 Participants	10 participants n=50 Participants

Timeframe: checked during CPR, duration of ROSC >20 min

Percentage of Participants with Return of Spontaneous Circulation (ROSC)

Outcome measures
Measure	1 (Sodium Bicarbonate) n=25 Participants Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes	2 (Normal Saline) n=25 Participants Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
Return of Spontaneous Circulation (ROSC)	4 ROSC percents of each group	16 ROSC percents of each group

Serious events: 25 serious events

Other events: 25 other events

Deaths: 24 deaths

Serious events: 24 serious events

Other events: 25 other events

Deaths: 21 deaths

Serious adverse events
Measure	1 (Sodium Bicarbonate) n=25 participants at risk Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes	2 (Normal Saline) n=25 participants at risk Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
Nervous system disorders Severe hypoxic brain injury	100.0% 25/25 • Number of events 25	96.0% 24/25 • Number of events 24

Other adverse events
Measure	1 (Sodium Bicarbonate) n=25 participants at risk Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes	2 (Normal Saline) n=25 participants at risk Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
Nervous system disorders Severe hypoxic brain injury (<6 mo)	100.0% 25/25 • Number of events 25	100.0% 25/25 • Number of events 25

Asan Medical Center

Phone: 8230103350