Blood Gas Analysis and Buffering In Cardiac Arrest (BABICA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Rate of return of spontaneous circulation (ROSC) [ Time Frame: Within five hours from start of resuscitation. ] [ Designated as safety issue: No ]
- Survival to discharge after cardiac arrest [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]Discharge from hospital
- Survival after one year of hospital discharge [ Time Frame: One year after event ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sodium Chloride
Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.
Drug: Sodium Chloride
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
Active Comparator: Sodium Bicarbonate
Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.
Drug: Sodium bicarbonate
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362556
|Klagenfurt, Carinthia, Austria, 9020|
|Landesklinikum Wiener Neustadt|
|Wiener Neustadt, Lower Austria, Austria, 2700|
|Landeskrankenhaus Bruck / Mur|
|Bruck / Mur, Styria, Austria, 8600|
|Medical University Graz|
|Graz, Styria, Austria, 8036|
|LKH Graz West|
|Graz, Styria, Austria, 8020|
|Linz, Upper Austria, Austria, 4021|
|Principal Investigator:||Gerhard Prause, Prof. Dr.||Medical University of Graz|