Blood Gas Analysis and Buffering In Cardiac Arrest

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01362556

Acronym

BABICA

Enrollment

700

Registered

2011-05-30

Start date

2011-03-31

Completion date

2014-06-30

Last updated

2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief 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.

Interventions

DRUGSodium 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

DRUGSodium 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of return of spontaneous circulation (ROSC)	Within five hours from start of resuscitation.

Secondary

Measure	Time frame	Description
Survival to discharge after cardiac arrest	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	Discharge from hospital
Survival after one year of hospital discharge	One year after event	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026