Cardiac ArrestBABICANCT01362556
Blood Gas Analysis and Buffering In Cardiac Arrest
A study testing Sodium bicarbonate and Sodium Chloride in people with Cardiac Arrest, run by Medical University of Graz at 6 sites in Austria.
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)". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Sodium bicarbonate and Sodium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 6 sitesAustria
- Study dates
- Mar 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- women of childbearing age
- traumatic cardiac arrest
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Austria6 sites
Landeskrankenhaus Bruck / Mur
Bruck / Mur, Styria, 8600
LKH Graz West
Graz, Styria, 8020
Medical University Graz
Graz, Styria, 8036
Landeskrankenhaus Klagenfurt
Klagenfurt, Carinthia, 9020
AKH Linz
Linz, Upper Austria, 4021
Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700
About this study
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
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.
- Conditions
- Cardiac Arrest
- Being tested
- Sodium bicarbonate, Sodium Chloride
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
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 ChlorideDrug
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 group | Role | What they receive |
|---|---|---|
| Sodium Chloride | Placebo comparator | Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest. Receives: Drug: Sodium Chloride |
| Sodium Bicarbonate | Active comparator | Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest. Receives: Drug: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of return of spontaneous circulation (ROSC)
Measured: Within five hours from start of resuscitation.
Secondary outcomes (2)
Survival to discharge after cardiac arrest
Discharge from hospital
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Survival after one year of hospital discharge
Measured: One year after event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prause Gerhard, MD, Medical University of Graz
- Investigators
- Gerhard Prause, Prof. Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362556
- Sponsor's protocol ID
- BABICA
- Acronym
- BABICA
- Status last verified
- Jun 2014
- First submitted
- 27 Apr 2011
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01362556
- Acronym / sponsor ID
- BABICA / BABICA
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Chloride | Placebo comparator | Drug: Sodium ChlorideGroup receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest. |
| Sodium Bicarbonate | Active comparator | Drug: Sodium bicarbonateGroup receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- prehospitally started cardiopulmonary resuscitation (CPR)
- advanced cardiac life support provided
- age >18 years
- arterial pH < 7,2
- arterial BE < -12
Key exclusion criteria (2 listed)
- women of childbearing age
- traumatic cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateAdministration 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 | Drug | Sodium Bicarbonate |
| Sodium ChlorideAdministration 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 | Drug | Sodium Chloride |
Primary outcome
Rate of return of spontaneous circulation (ROSC)
Time frame: Within five hours from start of resuscitation.
2 secondary outcomes
Survival to discharge after cardiac arrest
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Survival after one year of hospital discharge
Time frame: One year after event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Prause, Prof. Dr. principal investigator
Medical University of Graz
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate and Sodium Chloride in people with Cardiac Arrest, run by Medical University of Graz at 6 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of return of spontaneous circulation (ROSC) (time frame: Within five hours from start of resuscitation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.