Cardiac ArrestPhase 2NCT00121524
Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome
A Phase 2 study testing Epinephrine, Intravenous needle and Atropine in people with Cardiac Arrest, run by Petter Andreas Steen at 1 site in Norway.
Trial summary
Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. 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?
- Epinephrine, Intravenous needle and Atropine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2003to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac arrest out-of-hospital
Who cannot join
- <18 years old
- Trauma as cause of arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Epinephrine and I.V. Needle on CPR Outcome
Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
Read the detailed description
In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.
- Conditions
- Cardiac Arrest
- Being tested
- Epinephrine, Intravenous needle, Atropine, Amiodarone
- Keywords
- cardiac arrest, resuscitation, epinephrine, intravenous, survival
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Adrenaline
Epinephrine 1 mg is given iv. every 3 min during CPR
Intravenous needleDevice
An intravenous needle in placed as soon as possible during CPR
AtropineDrug
Also called Atropine sulfate
Atropine 3 mg iv in initial systole
AmiodaroneDrug
Also called Amiodaron
amiodarone 300 mg iv after repeated failed defibrillation attempts
| Study group | Role | What they receive |
|---|---|---|
| IV yes | Experimental | Intravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts Receives: Drug: Epinephrine; Device: Intravenous needle; Drug: Atropine; Drug: Amiodarone |
| IV no | No intervention | The patient will not have an intravenous needle placed or given any drugs during CPR. If patient obtains spontaneous circulation, an intravenous needle is placed and patient can receive any drugs that are appropriate during the following treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival to hospital discharge with neurologic outcome
Measured: discharge from hospital
Secondary outcomes (2)
admit to hospital with spontaneous circulation
Measured: hospital admission
one year survival with neurologic outcome
Measured: one year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJan 2003
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petter Andreas Steen
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, University of Oslo
- Responsible party
- Sponsor-investigator, Petter Andreas Steen, University of Oslo
- Investigators
- Lars Wik, MD, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121524
- Sponsor's protocol ID
- 525-02201
- Status last verified
- May 2015
- First submitted
- 13 Jul 2005
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holmberg M, Holmberg S, Herlitz J. Low chance of survival among patients requiring adrenaline (epinephrine) or intubation after out-of-hospital cardiac arrest in Sweden. Resuscitation. 2002 Jul;54(1):37-45. doi: 10.1016/s0300-9572(02)00048-5.
PubMed 12104107Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L. Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. JAMA. 2009 Nov 25;302(20):2222-9. doi: 10.1001/jama.2009.1729.
PubMed 19934423
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epinephrine and I.V. Needle on CPR Outcome
- ClinicalTrials.gov ID
- NCT00121524
- Acronym / sponsor ID
- 525-02201
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, resuscitation, epinephrine, intravenous, survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 904 participants (actual)
- Lead sponsor
- Petter Andreas SteenUniversity, hospital or other
- Collaborators
- Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, University of Oslo
- Study start
- Jan 2003
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Jul 2005 (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.
Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
Detailed description
In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV yes | Experimental | Drug: Epinephrine, Device: Intravenous needle, Drug: Atropine, Drug: AmiodaroneIntravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts |
| IV no | No intervention | –The patient will not have an intravenous needle placed or given any drugs during CPR. If patient obtains spontaneous circulation, an intravenous needle is placed and patient can receive any drugs that are appropriate during the following treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac arrest out-of-hospital
Key exclusion criteria (2 listed)
- <18 years old
- Trauma as cause of 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 |
|---|---|---|
| EpinephrineAlso: AdrenalineEpinephrine 1 mg is given iv. every 3 min during CPR | Drug | IV yes |
| Intravenous needleAn intravenous needle in placed as soon as possible during CPR | Device | IV yes |
| AtropineAlso: Atropine sulfateAtropine 3 mg iv in initial systole | Drug | IV yes |
| AmiodaroneAlso: Amiodaronamiodarone 300 mg iv after repeated failed defibrillation attempts | Drug | IV yes |
Primary outcome
survival to hospital discharge with neurologic outcome
Time frame: discharge from hospital
2 secondary outcomes
admit to hospital with spontaneous circulation
Time frame: hospital admission
one year survival with neurologic outcome
Time frame: one year after hospital discharge
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 29 May 2015.
- Background: PubMed 12104107Holmberg M, Holmberg S, Herlitz J. Low chance of survival among patients requiring adrenaline (epinephrine) or intubation after out-of-hospital cardiac arrest in Sweden. Resuscitation. 2002 Jul;54(1):37-45. doi: 10.1016/s0300-9572(02)00048-5.
- Derived from this study: PubMed 19934423Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L. Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. JAMA. 2009 Nov 25;302(20):2222-9. doi: 10.1001/jama.2009.1729.
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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.
Lars Wik, MD, PhD principal investigator
Ullevaal University 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 Epinephrine, Intravenous needle and Atropine in people with Cardiac Arrest, run by Petter Andreas Steen at 1 site in Norway.
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 1 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 29 May 2015. 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 Norway. 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?
survival to hospital discharge with neurologic outcome (time frame: discharge from hospital). 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 NCT00121524, which also lists 2 linked publications.
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 29 May 2015.