Out-Of-Hospital Cardiac ArrestMOSAICNCT04997980
AMSA and Amiodarone Study in Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 4 sites in 3 countries.
Trial summary
Investigators' aim is to assess whether the administration of amiodarone during resuscitation could cause a reduction of the values of the amplitude spectral area (AMSA). Amiodarone is recommended for the treatment of cardiac arrest due to ventricular tachycardia/ventricular fibrillation (VT/VF) ( with a low level of… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Amiodarone Injection
- Type of treatment
- Injection or infusion
- How many people
- 629 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jan 2015to 31 Dec 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the consecutive patients suffering of out-of-hospital cardiac arrest with a shockable presenting rhythm and receiving an advanced attempt of resuscitation.
Who may be able to join
- clinical:
- patients with out-of-hospital cardiac arrest
- shockable presenting rhythm
- resuscitation attempted
- advanced resuscitation attempted
- technical: - VF cardiac arrest (and not VT)
Who cannot join
- clinical:
- non-shockable presenting rhythm
- resuscitation not attempted
- technical:
- AMSA not evaluable
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Norway2 sites
Oslo University Hospital
Oslo, 0010
Vestfold Hospital trust
Tønsberg
About this study
Official title: aMsa and amiOdarone Study in cArdiaC Arrest
Investigators' aim is to assess whether the administration of amiodarone during resuscitation could cause a reduction of the values of the amplitude spectral area (AMSA).
Amiodarone is recommended for the treatment of cardiac arrest due to ventricular tachycardia/ventricular fibrillation (VT/VF) ( with a low level of recommendation cause of conflicting results. AMSA is a parameter expressing the amplitude of VF and it has been shown to predict defibrillation success and the return of spontaneous circulation (ROSC). No data are available so far about the impact of amiodarone administration on AMSA values.
Read the detailed description
The primary study endpoint of the present study is to determine whether patients who received amiodarone during advanced resuscitation had lower values of AMSA as compared to those who did not receive amiodarone.
Secondary endpoints
The secondary endpoints of this study are:
- To assess, after correction for confounders, the rate of successful defibrillation, the rate of ROSC and the rate of short-term survival (survived event or survival to hospital discharge according to the available data) both in the amiodarone and non-amiodarone group.
- To assess the role of AMSA for shock success and ROSC prediction in amiodarone group and in non-amiodarone group.
Type of study. This is a multicentre study based on a retrospective analysis of prospectically collected data.
Study population All the out-of-hospital cardiac arrests (OHCA) which occurred from January 1st, 2015 to December 31st, 2020 will be considered for the present study. In the analysis the investigators will include only those patients who received at least one shock for ventricular fibrillation during advanced resuscitation regardless whether or not the presenting rhythm was shockable or non-shockable.
The study cohort will involve cases retrieved from the Lombardia CARe registry (Lombardia Cardiac Arrest Registry NCT03197142), from the registry of Oslo and Vestfold
Data Collection Data from different databases will be integrated and combined in a single ad hoc database for statistical analysis.
For every shock, both pre-shock carbon dioxide at the end ot the tidal volume (ETCO2) and pre-shock AMSA will be calculated. The median ETCO2 value in the minute before the shock (METCO2) will be computed automatically either from a capnogram, when available, applying the algorithm described by Aramendi et al, or from the defibrillator with a ETCO2 monitoring feature. AMSA will be computed using a 2-second-pre-shock ECG interval, free of chest compression artifacts, leaving a 1-second guard before the shock. The electrocardiogram (ECG) will be bandpass filtered (0.5-30Hz) and the fast Fourier transform computed to obtain AMSA in the 2-48 Hz bandwidth.
For each patient all the pre-hospital variables will be included according to the 2014 Utstein recommendations and the number of shocks will be computed. The mean value of both ETCO2 and of AMSA will be calculated.
Statistical analysis Categorical variables will be compared with the Chi-square test and presented as number and percentage. Continuous variables will be compared with the t-test and presented as mean ± standard deviation, or compared with the Mann-Whitney test and presented as median and interquartile range (IQR) according to normal distribution tested with the D'Agostino-Pearson test. A multivariable regression model will be fitted both for shock success and for ROSC (including all non-correlated potential predictors) and to test the effect of amiodarone on AMSA values after correction for confounders.
The values of AMSA in the amiodarone and in the non-amiodarone group will then be compared in two groups of shocks randomly matched and identified via propensity score matching, so that they are homogeneous for time to shock, pre-shock ETCO2, outcome of defibrillation and the age of the patients.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Amiodarone Injection
- Keywords
- AMSA, amiodarone, Out-Of-Hospital Cardiac Arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone group | Patients who did receive amiodarone during the attempt of resuscitation Receives: Drug: Amiodarone Injection | |
| NO Amiodarone | Patients who did receive amiodarone during the attempt of resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMSA values
to determine whether AMSA values in the Amiodarone group are lower than in the NO Amiodarone gorup
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Successful defibrilaltion
to assess the rate of successful defibrillation in the Amiodarone and in the NO Amiodarone group
Measured: through study completion, an average of 1 year
ROSC
to assess the rate of ROSC in the Amiodarone and in the NO Amiodarone group
Measured: through study completion, an average of 1 year
Survived event
to assess the rate of "survived event" in the Amiodarone and in the NO Amiodarone group
Measured: through study completion, an average of 1 year
Survival to hospital discharge
to assess the rate of survival to hospital discharge in the Amiodarone and in the NO Amiodarone group
Measured: through study completion, an average of 1 year
Prediction
to verify if AMSA maintain its predictive role for defibrillation success and ROSC also in the Amiodarone group
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Oslo University Hospital, The Hospital of Vestfold
- Responsible party
- Principal investigator, Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997980
- Sponsor's protocol ID
- IRCCSPSM 1
- Acronym
- MOSAIC
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data could be shared under motivated request following a proposal.
Publications
Schwartz PJ, Zaza A. The Sicilian Gambit revisited--theory and practice. Eur Heart J. 1992 Nov;13 Suppl F:23-9. doi: 10.1093/eurheartj/13.suppl_f.23. No abstract available.
PubMed 1478220Zipes DP, Prystowsky EN, Heger JJ. Amiodarone: electrophysiologic actions, pharmacokinetics and clinical effects. J Am Coll Cardiol. 1984 Apr;3(4):1059-71. doi: 10.1016/s0735-1097(84)80367-8.
PubMed 6368644Marinchak RA, Friehling TD, Kline RA, Stohler J, Kowey PR. Effect of antiarrhythmic drugs on defibrillation threshold: case report of an adverse effect of mexiletine and review of the literature. Pacing Clin Electrophysiol. 1988 Jan;11(1):7-12. doi: 10.1111/j.1540-8159.1988.tb03925.x.
PubMed 2449675Zhou L, Chen BP, Kluger J, Fan C, Chow MS. Effects of amiodarone and its active metabolite desethylamiodarone on the ventricular defibrillation threshold. J Am Coll Cardiol. 1998 Jun;31(7):1672-8. doi: 10.1016/s0735-1097(98)00160-0.
PubMed 9626850Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. doi: 10.1161/CIRCULATIONAHA.106.618421. Epub 2006 Jul 3.
PubMed 16818810Jung W, Manz M, Pizzulli L, Pfeiffer D, Luderitz B. Effects of chronic amiodarone therapy on defibrillation threshold. Am J Cardiol. 1992 Oct 15;70(11):1023-7. doi: 10.1016/0002-9149(92)90354-2.
PubMed 1414899Fain ES, Lee JT, Winkle RA. Effects of acute intravenous and chronic oral amiodarone on defibrillation energy requirements. Am Heart J. 1987 Jul;114(1 Pt 1):8-17. doi: 10.1016/0002-8703(87)90300-0.
PubMed 3604876Soar J, Berg KM, Andersen LW, Bottiger BW, Cacciola S, Callaway CW, Couper K, Cronberg T, D'Arrigo S, Deakin CD, Donnino MW, Drennan IR, Granfeldt A, Hoedemaekers CWE, Holmberg MJ, Hsu CH, Kamps M, Musiol S, Nation KJ, Neumar RW, Nicholson T, O'Neil BJ, Otto Q, de Paiva EF, Parr MJA, Reynolds JC, Sandroni C, Scholefield BR, Skrifvars MB, Wang TL, Wetsch WA, Yeung J, Morley PT, Morrison LJ, Welsford M, Hazinski MF, Nolan JP; Adult Advanced Life Support Collaborators. Adult Advanced Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2020 Nov;156:A80-A119. doi: 10.1016/j.resuscitation.2020.09.012. Epub 2020 Oct 21.
PubMed 33099419Sanfilippo F, Corredor C, Santonocito C, Panarello G, Arcadipane A, Ristagno G, Pellis T. Amiodarone or lidocaine for cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Oct;107:31-7. doi: 10.1016/j.resuscitation.2016.07.235. Epub 2016 Aug 3.
PubMed 27496262Tagami T, Yasunaga H, Yokota H. Antiarrhythmic drugs for out-of-hospital cardiac arrest with refractory ventricular fibrillation. Crit Care. 2017 Mar 21;21(1):59. doi: 10.1186/s13054-017-1639-8.
PubMed 28320450Tagami T, Matsui H, Tanaka C, Kaneko J, Kuno M, Ishinokami S, Unemoto K, Fushimi K, Yasunaga H. Amiodarone Compared with Lidocaine for Out-Of-Hospital Cardiac Arrest with Refractory Ventricular Fibrillation on Hospital Arrival: a Nationwide Database Study. Cardiovasc Drugs Ther. 2016 Oct;30(5):485-491. doi: 10.1007/s10557-016-6689-7.
PubMed 27618826Chowdhury A, Fernandes B, Melhuish TM, White LD. Antiarrhythmics in Cardiac Arrest: A Systematic Review and Meta-Analysis. Heart Lung Circ. 2018 Mar;27(3):280-290. doi: 10.1016/j.hlc.2017.07.004. Epub 2017 Aug 23.
PubMed 28988724Zhao H, Fan K, Feng G. Amiodarone and/or lidocaine for cardiac arrest: A Bayesian network meta-analysis. Am J Emerg Med. 2020 Oct;38(10):2185-2193. doi: 10.1016/j.ajem.2020.06.074. Epub 2020 Jul 5.
PubMed 33071078Ong ME, Pellis T, Link MS. The use of antiarrhythmic drugs for adult cardiac arrest: a systematic review. Resuscitation. 2011 Jun;82(6):665-70. doi: 10.1016/j.resuscitation.2011.02.033. Epub 2011 Mar 27.
PubMed 21444143Kudenchuk PJ, Leroux BG, Daya M, Rea T, Vaillancourt C, Morrison LJ, Callaway CW, Christenson J, Ornato JP, Dunford JV, Wittwer L, Weisfeldt ML, Aufderheide TP, Vilke GM, Idris AH, Stiell IG, Colella MR, Kayea T, Egan D, Desvigne-Nickens P, Gray P, Gray R, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators. Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo). Circulation. 2017 Nov 28;136(22):2119-2131. doi: 10.1161/CIRCULATIONAHA.117.028624. Epub 2017 Sep 13.
PubMed 28904070
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- aMsa and amiOdarone Study in cArdiaC Arrest
- ClinicalTrials.gov ID
- NCT04997980
- Acronym / sponsor ID
- MOSAIC / IRCCSPSM 1
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- AMSA, amiodarone, Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Oslo University Hospital, The Hospital of Vestfold
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Aug 2021 (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.
Investigators' aim is to assess whether the administration of amiodarone during resuscitation could cause a reduction of the values of the amplitude spectral area (AMSA).
Amiodarone is recommended for the treatment of cardiac arrest due to ventricular tachycardia/ventricular fibrillation (VT/VF) ( with a low level of recommendation cause of conflicting results. AMSA is a parameter expressing the amplitude of VF and it has been shown to predict defibrillation success and the return of spontaneous circulation (ROSC). No data are available so far about the impact of amiodarone administration on AMSA values.
Detailed description
The primary study endpoint of the present study is to determine whether patients who received amiodarone during advanced resuscitation had lower values of AMSA as compared to those who did not receive amiodarone.
Secondary endpoints
The secondary endpoints of this study are:
- To assess, after correction for confounders, the rate of successful defibrillation, the rate of ROSC and the rate of short-term survival (survived event or survival to hospital discharge according to the available data) both in the amiodarone and non-amiodarone group.
- To assess the role of AMSA for shock success and ROSC prediction in amiodarone group and in non-amiodarone group.
Type of study. This is a multicentre study based on a retrospective analysis of prospectically collected data.
Study population All the out-of-hospital cardiac arrests (OHCA) which occurred from January 1st, 2015 to December 31st, 2020 will be considered for the present study. In the analysis the investigators will include only those patients who received at least one shock for ventricular fibrillation during advanced resuscitation regardless whether or not the presenting rhythm was shockable or non-shockable.
The study cohort will involve cases retrieved from the Lombardia CARe registry (Lombardia Cardiac Arrest Registry NCT03197142), from the registry of Oslo and Vestfold
Data Collection Data from different databases will be integrated and combined in a single ad hoc database for statistical analysis.
For every shock, both pre-shock carbon dioxide at the end ot the tidal volume (ETCO2) and pre-shock AMSA will be calculated. The median ETCO2 value in the minute before the shock (METCO2) will be computed automatically either from a capnogram, when available, applying the algorithm described by Aramendi et al, or from the defibrillator with a ETCO2 monitoring feature. AMSA will be computed using a 2-second-pre-shock ECG interval, free of chest compression artifacts, leaving a 1-second guard before the shock. The electrocardiogram (ECG) will be bandpass filtered (0.5-30Hz) and the fast Fourier transform computed to obtain AMSA in the 2-48 Hz bandwidth.
For each patient all the pre-hospital variables will be included according to the 2014 Utstein recommendations and the number of shocks will be computed. The mean value of both ETCO2 and of AMSA will be calculated.
Statistical analysis Categorical variables will be compared with the Chi-square test and presented as number and percentage. Continuous variables will be compared with the t-test and presented as mean ± standard deviation, or compared with the Mann-Whitney test and presented as median and interquartile range (IQR) according to normal distribution tested with the D'Agostino-Pearson test. A multivariable regression model will be fitted both for shock success and for ROSC (including all non-correlated potential predictors) and to test the effect of amiodarone on AMSA values after correction for confounders.
The values of AMSA in the amiodarone and in the non-amiodarone group will then be compared in two groups of shocks randomly matched and identified via propensity score matching, so that they are homogeneous for time to shock, pre-shock ETCO2, outcome of defibrillation and the age of the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone group | – | Drug: Amiodarone InjectionPatients who did receive amiodarone during the attempt of resuscitation |
| NO Amiodarone | – | –Patients who did receive amiodarone during the attempt of resuscitation |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the consecutive patients suffering of out-of-hospital cardiac arrest with a shockable presenting rhythm and receiving an advanced attempt of resuscitation.
Key inclusion criteria (6 listed)
- patients with out-of-hospital cardiac arrest
- shockable presenting rhythm
- resuscitation attempted
- advanced resuscitation attempted
- technical: - VF cardiac arrest (and not VT)
Key exclusion criteria (5 listed)
- non-shockable presenting rhythm
- resuscitation not attempted
- AMSA not evaluable
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 |
|---|---|---|
| Amiodarone Injection | Drug | Amiodarone group |
Primary outcome
AMSA values
Time frame: through study completion, an average of 1 year
to determine whether AMSA values in the Amiodarone group are lower than in the NO Amiodarone gorup
5 secondary outcomes
Successful defibrilaltion
Time frame: through study completion, an average of 1 year
ROSC
Time frame: through study completion, an average of 1 year
Survived event
Time frame: through study completion, an average of 1 year
Survival to hospital discharge
Time frame: through study completion, an average of 1 year
Prediction
Time frame: through study completion, an average of 1 year
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 8 Mar 2024.
- Background: PubMed 1478220Schwartz PJ, Zaza A. The Sicilian Gambit revisited--theory and practice. Eur Heart J. 1992 Nov;13 Suppl F:23-9. doi: 10.1093/eurheartj/13.suppl_f.23. No abstract available.
- Background: PubMed 6368644Zipes DP, Prystowsky EN, Heger JJ. Amiodarone: electrophysiologic actions, pharmacokinetics and clinical effects. J Am Coll Cardiol. 1984 Apr;3(4):1059-71. doi: 10.1016/s0735-1097(84)80367-8.
- Background: PubMed 2449675Marinchak RA, Friehling TD, Kline RA, Stohler J, Kowey PR. Effect of antiarrhythmic drugs on defibrillation threshold: case report of an adverse effect of mexiletine and review of the literature. Pacing Clin Electrophysiol. 1988 Jan;11(1):7-12. doi: 10.1111/j.1540-8159.1988.tb03925.x.
- Background: PubMed 9626850Zhou L, Chen BP, Kluger J, Fan C, Chow MS. Effects of amiodarone and its active metabolite desethylamiodarone on the ventricular defibrillation threshold. J Am Coll Cardiol. 1998 Jun;31(7):1672-8. doi: 10.1016/s0735-1097(98)00160-0.
- Background: PubMed 16818810Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. doi: 10.1161/CIRCULATIONAHA.106.618421. Epub 2006 Jul 3.
- Background: PubMed 1414899Jung W, Manz M, Pizzulli L, Pfeiffer D, Luderitz B. Effects of chronic amiodarone therapy on defibrillation threshold. Am J Cardiol. 1992 Oct 15;70(11):1023-7. doi: 10.1016/0002-9149(92)90354-2.
- Background: PubMed 3604876Fain ES, Lee JT, Winkle RA. Effects of acute intravenous and chronic oral amiodarone on defibrillation energy requirements. Am Heart J. 1987 Jul;114(1 Pt 1):8-17. doi: 10.1016/0002-8703(87)90300-0.
- Background: PubMed 33099419Soar J, Berg KM, Andersen LW, Bottiger BW, Cacciola S, Callaway CW, Couper K, Cronberg T, D'Arrigo S, Deakin CD, Donnino MW, Drennan IR, Granfeldt A, Hoedemaekers CWE, Holmberg MJ, Hsu CH, Kamps M, Musiol S, Nation KJ, Neumar RW, Nicholson T, O'Neil BJ, Otto Q, de Paiva EF, Parr MJA, Reynolds JC, Sandroni C, Scholefield BR, Skrifvars MB, Wang TL, Wetsch WA, Yeung J, Morley PT, Morrison LJ, Welsford M, Hazinski MF, Nolan JP; Adult Advanced Life Support Collaborators. Adult Advanced Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2020 Nov;156:A80-A119. doi: 10.1016/j.resuscitation.2020.09.012. Epub 2020 Oct 21.
- Background: PubMed 27496262Sanfilippo F, Corredor C, Santonocito C, Panarello G, Arcadipane A, Ristagno G, Pellis T. Amiodarone or lidocaine for cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Oct;107:31-7. doi: 10.1016/j.resuscitation.2016.07.235. Epub 2016 Aug 3.
- Background: PubMed 28320450Tagami T, Yasunaga H, Yokota H. Antiarrhythmic drugs for out-of-hospital cardiac arrest with refractory ventricular fibrillation. Crit Care. 2017 Mar 21;21(1):59. doi: 10.1186/s13054-017-1639-8.
- Background: PubMed 27618826Tagami T, Matsui H, Tanaka C, Kaneko J, Kuno M, Ishinokami S, Unemoto K, Fushimi K, Yasunaga H. Amiodarone Compared with Lidocaine for Out-Of-Hospital Cardiac Arrest with Refractory Ventricular Fibrillation on Hospital Arrival: a Nationwide Database Study. Cardiovasc Drugs Ther. 2016 Oct;30(5):485-491. doi: 10.1007/s10557-016-6689-7.
- Background: PubMed 28988724Chowdhury A, Fernandes B, Melhuish TM, White LD. Antiarrhythmics in Cardiac Arrest: A Systematic Review and Meta-Analysis. Heart Lung Circ. 2018 Mar;27(3):280-290. doi: 10.1016/j.hlc.2017.07.004. Epub 2017 Aug 23.
- Individual participant dataSharing planned: No. Data could be shared under motivated request following a proposal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 4 sites in 3 countries.
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 6 inclusion and 5 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Italy, Spain. 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?
AMSA values (time frame: through study completion, an average of 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 NCT04997980, which also lists 28 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 8 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.