Blood Gas Analysis and Buffering In Cardiac Arrest (BABICA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prause Gerhard, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01362556
First received: April 27, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cardiac Arrest
Drug: Sodium bicarbonate
Drug: Sodium Chloride

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Rate of return of spontaneous circulation (ROSC) [ Time Frame: Within five hours from start of resuscitation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362556

Locations
Austria
Landeskrankenhaus Klagenfurt
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
AKH Linz
Linz, Upper Austria, Austria, 4021
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Gerhard Prause, Prof. Dr. Medical University of Graz
  More Information

No publications provided

Responsible Party: Prause Gerhard, MD, Prof Dr, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01362556     History of Changes
Other Study ID Numbers: BABICA
Study First Received: April 27, 2011
Last Updated: June 2, 2014
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014