AMSA and Amiodarone Study in Cardiac Arrest

NCT04997980 | Completed

• 1 other identifier: IRCCSPSM 1
• Study Type: observational
• Target: 629
• Locations: 3 countries
• Sites: 4

Brief 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 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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

AMSA; amiodarone; Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• AMSA values

  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 Outcomes (5)

• Successful defibrilaltion

  through study completion, an average of 1 year

• ROSC

  through study completion, an average of 1 year

• Survived event

  through study completion, an average of 1 year

• Survival to hospital discharge

  through study completion, an average of 1 year

• Prediction

  through study completion, an average of 1 year

Study Arms (2)

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

Interventions

Amiodarone Injection DRUG

Amiodarone group

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinical:
• patients with out-of-hospital cardiac arrest
• shockable presenting rhythm
• resuscitation attempted
• advanced resuscitation attempted
• technical: - VF cardiac arrest (and not VT)

You may not qualify if:

• clinical:
• non-shockable presenting rhythm
• resuscitation not attempted
• technical:
• \- AMSA not evaluable

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• University of the Basque Country (UPV/EHU): collaborator
• Oslo University Hospital: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (4)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Oslo University Hospital

Oslo, 0010, Norway

Location

Vestfold Hospital trust

Tønsberg, Norway

Location

BioRes Research Group

Bilbao, Spain

Location

Related Publications (28)

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MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 10, 2021
• Study Start: January 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1); NO (2)