Heart ArrestNCT04149730
Adrenaline During Resuscitation From Pulseless Electrical Activity
An observational study of Heart Arrest, run by St. Olavs Hospital at 2 sites in 2 countries.
Trial summary
This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- How many people
- 280 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Mar 2019to 15 May 2023
- Phase
- Observational
- 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
Study population: The population will consist of patients suffering cardiac arrest while being hospitalized at St. Olavs hospital.
Inclusion Criteria: Cardiac arrest among hospitalized patients presenting with PEA as the primary rhythm.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type of cardiac arrest. ECG changes may be useful as a prognostic marker during resuscitation from PEA. In addition the researchers will describe the effect of adrenaline and chest compressions on clinical state transitions during resuscitation from pulseless electrical activity. Clinical state transitions are changes between different types of cardiac arrest. This study is expected to increase our understanding of the dynamics during treatment of cardiac arrest.
- Conditions
- Heart Arrest
- Keywords
- Epinephrine, Pulseless electrical activity
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary PEA. | Patients at St. Olavs hospital who suffer cardiac arrest and pulseless electrical activity (PEA) as primary rhythm during 2018-2021. 120 episodes from St. Olavs hospital were collected previously (2010-2013). In addition 200 cases will be available from the hospital of The University of Pennsylvania, Philadelphia, USA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS frequency
Measurement of RR intervals in milliseconds.
Measured: Every 3 minutes from start till end of cardiopulmonary resuscitation
QRS width
Measurement of the width of QRS complexes in milliseconds
Measured: Every 3 minutes from start till end of cardiopulmonary resuscitation
Changes of clinical states
changes of clinical states (for example from Pulseless electrical activity to Ventricular fibrillation) during treatment of cardiac arrest.
Measured: Every 3 minutes from start till end of cardiopulmonary resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start20 Mar 2019
- Primary completion1 Jan 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Eirik Skogvoll, md prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149730
- Sponsor's protocol ID
- 2019/785
- Status last verified
- Sep 2023
- First submitted
- 18 Oct 2019
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenaline During Resuscitation From Pulseless Electrical Activity
- ClinicalTrials.gov ID
- NCT04149730
- Acronym / sponsor ID
- 2019/785
- Conditions
- Heart Arrest
- Keywords
- Epinephrine, Pulseless electrical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Pennsylvania
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- 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.
This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type of cardiac arrest. ECG changes may be useful as a prognostic marker during resuscitation from PEA. In addition the researchers will describe the effect of adrenaline and chest compressions on clinical state transitions during resuscitation from pulseless electrical activity. Clinical state transitions are changes between different types of cardiac arrest. This study is expected to increase our understanding of the dynamics during treatment of cardiac arrest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary PEA. | – | –Patients at St. Olavs hospital who suffer cardiac arrest and pulseless electrical activity (PEA) as primary rhythm during 2018-2021. 120 episodes from St. Olavs hospital were collected previously (2010-2013). In addition 200 cases will be available from the hospital of The University of Pennsylvania, Philadelphia, USA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of patients suffering cardiac arrest while being hospitalized at St. Olavs hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QRS frequency
Time frame: Every 3 minutes from start till end of cardiopulmonary resuscitation
Measurement of RR intervals in milliseconds.
QRS width
Time frame: Every 3 minutes from start till end of cardiopulmonary resuscitation
Measurement of the width of QRS complexes in milliseconds
Changes of clinical states
Time frame: Every 3 minutes from start till end of cardiopulmonary resuscitation
changes of clinical states (for example from Pulseless electrical activity to Ventricular fibrillation) during treatment of cardiac arrest.
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 5 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Eirik Skogvoll, md prof study director
St. Olavs Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest, run by St. Olavs Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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.
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?
QRS frequency (time frame: Every 3 minutes from start till end of cardiopulmonary resuscitation). The study lists 3 primary outcomes in all. 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 5 Sep 2023.