Cardiac ArrestPhase 2NCT00312273
Aminophylline in Bradyasystolic Cardiac Arrest
A Phase 2 study testing Aminophylline (250mg IV +/- a second dose of 250mg IV) in people with Cardiac Arrest, run by Vancouver General Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Aminophylline (250mg IV +/- a second dose of 250mg IV)
- Type of treatment
- Injection or infusion
- How many people
- 966 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2001to Jul 2004
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac arrest
- Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation
- Endotracheally intubated and ventilated with 100% oxygen
- Intravenous (IV) access established
- Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.
Who cannot join
- A do-not-resuscitate directive
- Pregnancy
- Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest
- Renal dialysis
- Theophylline hypersensitivity
- Patients taking an oral theophylline product
- Resuscitations directed by a paramedic student under practicum supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
Read the detailed description
Out-of-hospital cardiac arrest treated by emergency medical services has an estimated incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes annually in the United States. Bradyasystole is the first recorded rhythm in up to 52 percent of cardiac arrests, and many additional patients with an initial cardiac arrest rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent of all cardiac arrest survivors. As a result, even a small improvement in survival from bradyasystolic cardiac arrest would result in thousands of lives saved annually.
Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and attenuates the effects of catecholamines. Since adenosine is produced and released by myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine. The use of aminophylline for bradycardia and heart block has been described, and a number of anecdotal reports and small studies have been published on the use of aminophylline in cardiac arrest. We undertook this study to evaluate the effect of aminophylline during cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac arrest unresponsive to initial therapy.
- Conditions
- Cardiac Arrest
- Being tested
- Aminophylline (250mg IV +/- a second dose of 250mg IV)
- Keywords
- Heart Arrest, Cardiopulmonary Resuscitation, Aminophylline, Bradycardia, Humans, Emergency Medical Services
- Medical subject headings
- Heart Arrest, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminophylline (250mg IV +/- a second dose of 250mg IV)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
Secondary outcomes (10)
Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
ROSC duration by survival analysis
Survival to hospital admission
Survival to hospital discharge
Length of hospital stay
Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
Seizures in the first 24 hours after study drug administration
Neurologic outcome
Proportion of subjects receiving one versus two doses of study drug
Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startJan 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 966 participants
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute
- Investigators
- Riyad B Abu Laban, MD, MHSc, Principal investigator, Department of Emergency Medicine, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312273
- Sponsor's protocol ID
- 20F35869
- Status last verified
- Sep 2003
- First submitted
- 5 Apr 2006
- Last updated
- 27 Jul 2006
- Results posted
- No
Publications
Abu-Laban RB, McIntyre CM, Christenson JM, van Beek CA, Innes GD, O'Brien RK, Wanger KP, McKnight RD, Gin KG, Zed PJ, Watts J, Puskaric J, MacPhail IA, Berringer RG, Milner RA. Aminophylline in bradyasystolic cardiac arrest: a randomised placebo-controlled trial. Lancet. 2006 May 13;367(9522):1577-84. doi: 10.1016/S0140-6736(06)68694-7.
PubMed 16698410
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00312273
- Acronym / sponsor ID
- 20F35869
- Conditions
- Cardiac Arrest
- Keywords
- Heart Arrest, Cardiopulmonary Resuscitation, Aminophylline, Bradycardia, Humans, Emergency Medical Services
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 966 participants
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute
- Study start
- Jan 2001
- Study completion
- Jul 2004
- First posted
- 7 Apr 2006 (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 purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
Detailed description
Out-of-hospital cardiac arrest treated by emergency medical services has an estimated incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes annually in the United States. Bradyasystole is the first recorded rhythm in up to 52 percent of cardiac arrests, and many additional patients with an initial cardiac arrest rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent of all cardiac arrest survivors. As a result, even a small improvement in survival from bradyasystolic cardiac arrest would result in thousands of lives saved annually.
Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and attenuates the effects of catecholamines. Since adenosine is produced and released by myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine. The use of aminophylline for bradycardia and heart block has been described, and a number of anecdotal reports and small studies have been published on the use of aminophylline in cardiac arrest. We undertook this study to evaluate the effect of aminophylline during cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac arrest unresponsive to initial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cardiac arrest
- Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation
- Endotracheally intubated and ventilated with 100% oxygen
- Intravenous (IV) access established
- Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.
Key exclusion criteria (7 listed)
- A do-not-resuscitate directive
- Pregnancy
- Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest
- Renal dialysis
- Theophylline hypersensitivity
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 |
|---|---|---|
| Aminophylline (250mg IV +/- a second dose of 250mg IV) | Drug | – |
Primary outcome
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
10 secondary outcomes
Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
ROSC duration by survival analysis
Survival to hospital admission
Survival to hospital discharge
Length of hospital stay
Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
Seizures in the first 24 hours after study drug administration
Neurologic outcome
Proportion of subjects receiving one versus two doses of study drug
Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.
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 27 Jul 2006.
- Results publication: PubMed 16698410Abu-Laban RB, McIntyre CM, Christenson JM, van Beek CA, Innes GD, O'Brien RK, Wanger KP, McKnight RD, Gin KG, Zed PJ, Watts J, Puskaric J, MacPhail IA, Berringer RG, Milner RA. Aminophylline in bradyasystolic cardiac arrest: a randomised placebo-controlled trial. Lancet. 2006 May 13;367(9522):1577-84. doi: 10.1016/S0140-6736(06)68694-7.
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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.
Riyad B Abu Laban, MD, MHSc principal investigator
Department of Emergency Medicine, Vancouver General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminophylline (250mg IV +/- a second dose of 250mg IV) in people with Cardiac Arrest, run by Vancouver General Hospital at 1 site in Canada.
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 5 inclusion and 7 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 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00312273, which also lists 1 linked publication.
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 27 Jul 2006.