Blood Gas Analysis and Buffering In Cardiac Arrest (BABICA)

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

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 Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Drug: Sodium Chloride; Drug: Sodium bicarbonate

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Carinthia
    • Klagenfurt, Carinthia, Austria, 9020
      • Landeskrankenhaus Klagenfurt
  • Lower Austria
    • Wiener Neustadt, Lower Austria, Austria, 2700
      • Landesklinikum Wiener Neustadt
  • Styria
    • Bruck / Mur, Styria, Austria, 8600
      • Landeskrankenhaus Bruck / Mur
    • Graz, Styria, Austria, 8020
      • LKH Graz West
    • Graz, Styria, Austria, 8036
      • Medical University Graz
  • Upper Austria
    • Linz, Upper Austria, Austria, 4021
      • AKH Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gerhard Prause, Prof. Dr., Medical University of Graz

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (ESTIMATE): May 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2014
• Last Update Submitted That Met QC Criteria: June 2, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: BABICA