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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Sodium bicarbonate) | Experimental | Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min |
|
| 2 (Normal saline) | Placebo Comparator | Normal saline 50cc intravenous injection over 2 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Administer Sodium bicarbonate 50 mEq IV over 2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Return of Spontaneous Circulation (ROSC) | Percentage of Participants with Return of Spontaneous Circulation (ROSC) | checked during CPR, duration of ROSC >20 min |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29850134 | Derived | Ahn S, Kim YJ, Sohn CH, Seo DW, Lim KS, Donnino MW, Kim WY. Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study. J Thorac Dis. 2018 Apr;10(4):2295-2302. doi: 10.21037/jtd.2018.03.124. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 (Sodium Bicarbonate) | Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes |
| FG001 | 2 (Normal Saline) | Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 (Sodium Bicarbonate) | Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes |
| BG001 | 2 (Normal Saline) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Return of Spontaneous Circulation (ROSC) | Percentage of Participants with Return of Spontaneous Circulation (ROSC) | Posted | Number | ROSC percents of each group | checked during CPR, duration of ROSC >20 min |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 (Sodium Bicarbonate) | Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoxic brain injury | Nervous system disorders | Systematic Assessment | Severe cerebral disabilities which occurred due to hypoxic brain injury such as conscious, but dependent on others for daily support because of impaired brain function, coma or vegetative state, or brain death within 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoxic brain injury (<6 mo) | Nervous system disorders | Systematic Assessment | Severe cerebral disabilities which occurred due to hypoxic brain injury such as conscious, but dependent on others for daily support because of impaired brain function, coma or vegetative state, or brain death within 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Asan Medical Center | 8230103350 | wonpia73@naver.com |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Normal saline | Drug | Placebo |
|
|
Normal saline 50cc intravenous injection over 2 min
Normal saline: Placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| pH | Median | Inter-Quartile Range | units on a scale |
|
| Shockable pre-hospital rhythm | Shockable pre-hospital rhythm: ventricular fibrillation or pulseless ventricular tachycardia rhythm detection before hospital admission | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 24 |
| 25 |
| 25 |
| 25 |
| 25 |
| 25 |
| EG001 | 2 (Normal Saline) | Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo | 21 | 25 | 24 | 25 | 25 | 25 |
|
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |