Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm (PARACA)

December 17, 2025 updated by: Hugo Bellut, Versailles Hospital

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.

To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
674

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
          • julien maizel, md
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Pierre ASFAR, MD
      • Annecy, France
        • Recruiting
        • CH Annecy Genevois
        • Contact:
          • davis bougon, md
      • Argenteuil, France
        • Recruiting
        • CH Argenteuil
        • Contact:
          • Gaetan Plantefeve, MD
      • Aurillac, France
        • Recruiting
        • CH Mondor
        • Contact:
          • Emanuele turbil, MD
      • Brest, France
        • Recruiting
        • CHU Brest
        • Contact:
          • pierre bailly, MD
      • Brive-la-Gaillarde, France
        • Recruiting
        • CH Brive
        • Contact:
          • cédric barucchi, MD
      • Caen, France
        • Not yet recruiting
        • CHU Caen
        • Contact:
          • cédric daubin, MD
      • Charleville-Mézières, France
        • Recruiting
        • Chi Nord Ardennes
        • Contact:
          • jérémy rosman, MD
      • Corbeil-Essonnes, France
        • Recruiting
        • CHSF
        • Contact:
          • sophie marques, md
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendée
        • Contact:
          • gwenhael colin, MD
      • La Rochelle, France
        • Recruiting
        • CH La Rochelle
        • Contact:
          • francois perrier, MD
      • Lyon, France
        • Recruiting
        • HCL
        • Contact:
          • jean christophe richard, MD
      • Marseille, France
        • Recruiting
        • Ap Hm
        • Contact:
          • jeremy bourenne
      • Massy, France
        • Recruiting
        • Hopital Cartier
        • Contact:
          • Wulfran BOUGOUIN, MD
      • Montreuil, France
        • Not yet recruiting
        • chi Gregoire
        • Contact:
          • vincent das, MD
      • Mulhouse, France
        • Recruiting
        • Hoptial Mulhouse
        • Contact:
          • guylaine labro, md
      • Nantes, France
        • Not yet recruiting
        • CHU Nantes
        • Contact:
          • jean baptiste lascarrou, MD
      • Neuilly-sur-Seine, France
        • Recruiting
        • Clinique Ambroise Pare
        • Contact:
          • Guillaume GERI, MD
      • Nice, France
        • Recruiting
        • CHU Nice -MIR Archet
        • Contact:
          • mathieu jozwiak
      • Nice, France
        • Recruiting
        • CHU Nice -MIR Pasteur
        • Contact:
          • denis doyen, MD
      • Orléans, France
        • Recruiting
        • CHU Orléans
        • Contact:
          • grégoire muller, MD
      • Paris, France
        • Recruiting
        • CHU Cochin
        • Contact:
          • alain coriou, MD
      • Paris, France
        • Recruiting
        • Hôpital Saint Joseph
        • Contact:
          • cedric bruel, MD
      • Poitiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
          • florence boissier, MD
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg
        • Contact:
          • antoine studer, md
      • Toulon, France
        • Recruiting
        • CHI Toulon
        • Contact:
          • noemie peres, MD
      • Toulouse, France
        • Recruiting
        • Chu Toulouse
        • Contact:
          • Clément DELMAS, MD
      • Valognes, France
        • Recruiting
        • CH Cotentin
        • Contact:
          • julien calus, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient aged ≥ 18 years
  2. Admitted in intensive care unit
  3. Out-of-hospital cardiac arrest with initial shockable rhythm
  4. Presumed cardiac or unknown cause
  5. Delay between ROSC and screening for randomisation < 6 hours
  6. Informed consent from the patient or a surrogate or deferred consent
  7. Affiliated to or benefiting from a social insurance

Exclusion Criteria:

  1. Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
  2. Indication for amiodarone decided by the physician at ICU admission
  3. No central venous catheter available for continuous infusion of amidoarone
  4. Thyroid disease under treatment
  5. History of cardiac conduction disorders, not treated by permanent pacemaker
  6. Any contra indication to amiodarone treatment
  7. Refractory ventricular arrhythmia or electrical storm
  8. Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
  9. Known limitations in therapy and Do Not Resuscitate-order
  10. Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
  11. Pregnant or breastfeeding women
  12. Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
  13. Patient with known pulmonary fibrosis
  14. Patient with known interstitial lung disease

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Amiodarone
Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.
Drug: Amiodarone
Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Mortality and severe ventricular arrhythmia
Time Frame: 30 days
The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of stay in hospital
Time Frame: 90 days
90 days
Length of ICU stay
Time Frame: 90 days
90 days
outcomes related with cardiac events
Time Frame: 90 days
  • Occurrence of ventricular fibrillation (VF)
  • Occurrence of ventricular tachycardia (VT) requiring or not intervention
  • Occurrence of atrial fibrillation (AF) and supraventricular tachycardia
  • Occurrence of cardiac re-arrest due to asystole
90 days
outcomes related with mortality
Time Frame: 90 days
  • ICU mortality
  • Hospital (and 30-day) mortality
  • Day 90 mortality
90 days
Duration of invasive mechanical ventilation
Time Frame: 90 days
90 days
Number of participants with outcomes related with amiodorane side effects
Time Frame: 5 days

Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion:

  • Conduction disorders
  • Hemodynamic consequences
  • Hepatic cytolysis
  • Anaphylaxis
5 days
Neurological outcome
Time Frame: 90 days
M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma)
90 days
Duration vasopressor infusion
Time Frame: 90 days
90 days
Dose of the anti-arrhythmic drugs
Time Frame: 90 days
90 days
Number of days of anti-arrhythmic drugs
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Versailles Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P23/08_PARACA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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