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The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Chloride | Placebo Comparator | Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest. |
|
| Sodium Bicarbonate | Active Comparator | Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Administration of a calculated amount of sodium bicarbonate 8% [SB] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg]. Formula: SB [ml] = -BE * kg * 0.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of return of spontaneous circulation (ROSC) | Within five hours from start of resuscitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to discharge after cardiac arrest | Discharge from hospital | participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
| Survival after one year of hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Prause, Prof. Dr. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Klagenfurt | Klagenfurt | Carinthia | 9020 | Austria | ||
| Landesklinikum Wiener Neustadt |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Sodium Chloride | Drug | Administration of a calculated amount of sodium chloride 0.9% [SC] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg]. Formula: SC [ml] = -BE * kg * 0.1 |
|
| One year after event |
| Wiener Neustadt |
| Lower Austria |
| 2700 |
| Austria |
| Landeskrankenhaus Bruck / Mur | Bruck / Mur | Styria | 8600 | Austria |
| LKH Graz West | Graz | Styria | 8020 | Austria |
| Medical University Graz | Graz | Styria | 8036 | Austria |
| AKH Linz | Linz | Upper Austria | 4021 | Austria |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |