Blood Gas Analysis and Buffering In Cardiac Arrest

Study Overview
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Brief Summary
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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.

Official Title
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Blood Gas Analysis and Buffering In Cardiac Arrest - A Multicenter, Prospective, Randomised, Double Blind Prehospital Trial to Evaluate the Impact of Early Blood-gas-analysis Targeted Buffer Therapy on ROSC After OOHCA

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prehospitally started cardiopulmonary resuscitation (CPR) advanced cardiac life support provided age >18 years arterial pH < 7,2 arterial BE < -12 arterial pCO2 15-75 mmHg arterial pO2 >35 mmHg Exclusion Criteria: women of childbearing age traumatic cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sodium Chloride<br>Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest. | Drug: Sodium Chloride<br>* 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<br>|
| Active Comparator: Sodium Bicarbonate<br>Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest. | Drug: Sodium bicarbonate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of return of spontaneous circulation (ROSC) |  | Within five hours from start of resuscitation. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | One year after event |