Blood Gas Analysis and Buffering In Cardiac Arrest

Cardiac Arrest Clinical Trial

— BABICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362556
• Other study ID #: BABICA
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: June 2, 2014
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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
• 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

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Bruck / Mur	Bruck / Mur	Styria
Austria	LKH Graz West	Graz	Styria
Austria	Medical University Graz	Graz	Styria
Austria	Landeskrankenhaus Klagenfurt	Klagenfurt	Carinthia
Austria	AKH Linz	Linz	Upper Austria
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of return of spontaneous circulation (ROSC)		Within five hours from start of resuscitation.	No
Secondary	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	No
Secondary	Survival after one year of hospital discharge		One year after event	No