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NCT Number: NCT01362556

Blood Gas Analysis and Buffering In Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landeskrankenhaus Klagenfurt, Klagenfurt, Carinthia, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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

Drug

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

Primary outcomes

  1. Rate of return of spontaneous circulation (ROSC)

    Time frame: Within five hours from start of resuscitation.

Secondary outcomes

  1. Survival to discharge after cardiac arrest

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    Discharge from hospital

  2. Survival after one year of hospital discharge

    Time frame: One year after event

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Acronym: BABICA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 30, 2011
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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