Heart ArrestNCT00920244
In-hospital Cardiac Arrest - Dynamics and State Transitions
An observational study of Heart Arrest and Death, Sudden, Cardiac, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Death, Sudden, Cardiac
- What is being tested?
- Cardiopulmonary resuscitation (CPR), Epinephrine and Atropine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 285 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2009to Apr 2015
- 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: Patients with in-hospital cardiac arrest at St.Olavs Hospital (Trondheim, Norway) during the study period.
Who may be able to join
- Patients with in-hospital cardiac arrest who are resuscitated
Who cannot join
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamics and State Transitions During Resuscitation in In-hospital Cardiac Arrest
The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest.
Read the detailed description
In-hospital cardiac arrest carries a grave prognosis, with survival to discharge in the range of 15-20%. Key factors determining outcome include the presenting cardiac rhythm, aetiology, and early initiation of resuscitation. Some cardiac rhythms benefit from defibrillation (shockable rhythms). During resuscitation patients may switch between shockable and non-shockable rhythms, and may show signs of spontaneous circulation temporarily. Depending on rhythm and according to guidelines, patients receive direct current (DC) shocks (defibrillator) and/or i.v. adrenaline, atropine and amiodarone, which may affect state-transitions. We wish to make statistical analysis (time-series analysis, Markov modelling) of these state-transitions and variations in hemodynamic variables during resuscitation, related to CPR interventions and the cause of arrest. The cause of arrest will be determined based on chart records, interview with staff and autopsy if appropriate. One hypothesis is that differences in the patterns of state-transitions may reflect underlying aetiology, which may guide in future decision-making during resuscitation.
- Conditions
- Heart Arrest, Death, Sudden, Cardiac
- Being tested
- Cardiopulmonary resuscitation (CPR), Epinephrine, Atropine, Amiodarone, External defibrillator
- Keywords
- Resuscitation, Cardiac arrest, State-transitions, Markov
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary resuscitation (CPR)Procedure or surgery
Also called CPR
CPR is performed according to international and national guidelines on all patients.
EpinephrineDrug
Also called Adrenaline
According to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation.
AtropineDrug
According to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min.
AmiodaroneDrug
Also called Cordarone
According to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR.
External defibrillatorDevice
Also called Defibrillator
According to CPR guidelines patients with shockable rhythms may receive DC shocks. The defibrillator also stores physiological information regarding cardiac rhythm, pulse-oximetry, and end-tidal carbon dioxide (CO2) from endotracheal tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge
Measured: 1 year
Secondary outcomes (1)
Short-term survival
Measured: minutes-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2015
- Study completionApr 2015
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 Heart ArrestStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Eirik Skogvoll, MD, PhD, Study chair, St. Olavs HospitalTrond Nordseth, MD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920244
- Sponsor's protocol ID
- 4.2008.2402 (REK)
- Other IDs
- 08/11457, 20708/2/IB
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2009
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Skjeflo GW, Nordseth T, Loennechen JP, Bergum D, Skogvoll E. ECG changes during resuscitation of patients with initial pulseless electrical activity are associated with return of spontaneous circulation. Resuscitation. 2018 Jun;127:31-36. doi: 10.1016/j.resuscitation.2018.03.039. Epub 2018 Apr 3.
PubMed 29621571Nordseth T, Bergum D, Edelson DP, Olasveengen TM, Eftestol T, Wiseth R, Abella BS, Skogvoll E. Clinical state transitions during advanced life support (ALS) in in-hospital cardiac arrest. Resuscitation. 2013 Sep;84(9):1238-44. doi: 10.1016/j.resuscitation.2013.04.010. Epub 2013 Apr 19.
PubMed 23603153
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics and State Transitions During Resuscitation in In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00920244
- Acronym / sponsor ID
- 4.2008.2402 (REK)
- Conditions
- Heart Arrest, Death, Sudden, Cardiac
- Keywords
- Resuscitation, Cardiac arrest, State-transitions, Markov
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, Norwegian University of Science and Technology
- Study start
- Aug 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Jun 2009 (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 analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest.
Detailed description
In-hospital cardiac arrest carries a grave prognosis, with survival to discharge in the range of 15-20%. Key factors determining outcome include the presenting cardiac rhythm, aetiology, and early initiation of resuscitation. Some cardiac rhythms benefit from defibrillation (shockable rhythms). During resuscitation patients may switch between shockable and non-shockable rhythms, and may show signs of spontaneous circulation temporarily. Depending on rhythm and according to guidelines, patients receive direct current (DC) shocks (defibrillator) and/or i.v. adrenaline, atropine and amiodarone, which may affect state-transitions. We wish to make statistical analysis (time-series analysis, Markov modelling) of these state-transitions and variations in hemodynamic variables during resuscitation, related to CPR interventions and the cause of arrest. The cause of arrest will be determined based on chart records, interview with staff and autopsy if appropriate. One hypothesis is that differences in the patterns of state-transitions may reflect underlying aetiology, which may guide in future decision-making during resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with in-hospital cardiac arrest at St.Olavs Hospital (Trondheim, Norway) during the study period.
Key inclusion criteria (1 listed)
- Patients with in-hospital cardiac arrest who are resuscitated
Key exclusion criteria (1 listed)
- Younger than 18 years old
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 |
|---|---|---|
| Cardiopulmonary resuscitation (CPR)Also: CPRCPR is performed according to international and national guidelines on all patients. | Procedure or surgery | – |
| EpinephrineAlso: AdrenalineAccording to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation. | Drug | – |
| AtropineAccording to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min. | Drug | – |
| AmiodaroneAlso: CordaroneAccording to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR. | Drug | – |
| External defibrillatorAlso: DefibrillatorAccording to CPR guidelines patients with shockable rhythms may receive DC shocks. The defibrillator also stores physiological information regarding cardiac rhythm, pulse-oximetry, and end-tidal carbon dioxide (CO2) from endotracheal tube. | Device | – |
Primary outcome
Survival to discharge
Time frame: 1 year
1 secondary outcome
Short-term survival
Time frame: minutes-days
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 2018.
- Results publication: PubMed 29621571Skjeflo GW, Nordseth T, Loennechen JP, Bergum D, Skogvoll E. ECG changes during resuscitation of patients with initial pulseless electrical activity are associated with return of spontaneous circulation. Resuscitation. 2018 Jun;127:31-36. doi: 10.1016/j.resuscitation.2018.03.039. Epub 2018 Apr 3.
- Derived from this study: PubMed 23603153Nordseth T, Bergum D, Edelson DP, Olasveengen TM, Eftestol T, Wiseth R, Abella BS, Skogvoll E. Clinical state transitions during advanced life support (ALS) in in-hospital cardiac arrest. Resuscitation. 2013 Sep;84(9):1238-44. doi: 10.1016/j.resuscitation.2013.04.010. Epub 2013 Apr 19.
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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, PhD study chair
St. Olavs Hospital
Trond Nordseth, MD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Death, Sudden, Cardiac, run by St. Olavs Hospital 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 1 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 5 Sep 2018. 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.
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 discharge (time frame: 1 year). 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 NCT00920244, 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 5 Sep 2018.