Cardiac Arrest, Metabolic Acidosis
Conditions
Keywords
Sodium Bicarbonate
Brief summary
A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.
Interventions
DRUGSodium bicarbonate
Administer Sodium bicarbonate 50 mEq IV over 2 minutes
DRUGNormal saline
Placebo
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult cardiac arrest patient with arterial pH \<7.1 or bicarbonate \<10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation
Exclusion criteria
* age \<18 trauma patient Do Not Resuscitate state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return of Spontaneous Circulation (ROSC) | checked during CPR, duration of ROSC >20 min | Percentage of Participants with Return of Spontaneous Circulation (ROSC) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 (Sodium Bicarbonate) Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min
Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes | 25 |
| 2 (Normal Saline) Normal saline 50cc intravenous injection over 2 min
Normal saline: Placebo | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | 1 (Sodium Bicarbonate) | 2 (Normal Saline) | Total |
|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 16.4 | 64.1 years STANDARD_DEVIATION 15.4 | 64.8 years STANDARD_DEVIATION 16 |
| pH | 6.99 units on a scale | 6.90 units on a scale | 6.95 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 18 Participants | 21 Participants | 39 Participants |
| Shockable pre-hospital rhythm | 7 participants | 3 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 25 | 21 / 25 |
| other Total, other adverse events | 25 / 25 | 25 / 25 |
| serious Total, serious adverse events | 25 / 25 | 24 / 25 |
Outcome results
Primary
Return of Spontaneous Circulation (ROSC)
Percentage of Participants with Return of Spontaneous Circulation (ROSC)
Time frame: checked during CPR, duration of ROSC >20 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 (Sodium Bicarbonate) | Return of Spontaneous Circulation (ROSC) | 4 ROSC percents of each group |
| 2 (Normal Saline) | Return of Spontaneous Circulation (ROSC) | 16 ROSC percents of each group |