AMSA and Amiodarone Study in Cardiac Arrest (MOSAIC)

March 7, 2024 updated by: Simone Savastano, IRCCS Policlinico S. Matteo

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.

Study Overview

Status

Completed

Conditions

Out-Of-Hospital Cardiac Arrest

Intervention / Treatment

Drug: Amiodarone Injection

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 Type

Observational

Enrollment (Actual)

629

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo
Norway
- - Oslo, Norway, 0010
    - Oslo University Hospital
  - Tønsberg, Norway
    - Vestfold Hospital trust
Spain
- - Bilbao, Spain
    - BioRes Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

clinical:

patients with out-of-hospital cardiac arrest
shockable presenting rhythm
resuscitation attempted
advanced resuscitation attempted

technical: - VF cardiac arrest (and not VT)

Exclusion Criteria:

clinical:

non-shockable presenting rhythm
resuscitation not attempted

technical:

- AMSA not evaluable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Amiodarone group Patients who did receive amiodarone during the attempt of resuscitation	Drug: Amiodarone Injection
NO Amiodarone Patients who did receive amiodarone during the attempt of resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful defibrilaltion Time Frame: through study completion, an average of 1 year	to assess the rate of successful defibrillation in the Amiodarone and in the NO Amiodarone group	through study completion, an average of 1 year
ROSC Time Frame: through study completion, an average of 1 year	to assess the rate of ROSC in the Amiodarone and in the NO Amiodarone group	through study completion, an average of 1 year
Survived event Time Frame: through study completion, an average of 1 year	to assess the rate of "survived event" in the Amiodarone and in the NO Amiodarone group	through study completion, an average of 1 year
Survival to hospital discharge Time Frame: through study completion, an average of 1 year	to assess the rate of survival to hospital discharge in the Amiodarone and in the NO Amiodarone group	through study completion, an average of 1 year
Prediction Time Frame: through study completion, an average of 1 year	to verify if AMSA maintain its predictive role for defibrillation success and ROSC also in the Amiodarone group	through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Collaborators

Oslo University Hospital

University of the Basque Country (UPV/EHU)

The Hospital of Vestfold

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 18, 2021

First Submitted That Met QC Criteria

August 1, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

IRCCSPSM 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Data could be shared under motivated request following a proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

AMSA and Amiodarone Study in Cardiac Arrest (MOSAIC)