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New treatment option for Ventricular Arrhythmias and Cardiac Arrest
Official title Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
ClinicalTrials.gov ID: NCT06835491
What this study is testing
What is Amiodarone?
Amiodarone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ventricular arrhythmias and cardiac arrest.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient aged ≥ 18 years
- Admitted in intensive care unit
- Out-of-hospital cardiac arrest with initial shockable rhythm
- Presumed cardiac or unknown cause
- Delay between ROSC and screening for randomisation \< 6 hours
You likely can't join if
- Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
- Indication for amiodarone decided by the physician at ICU admission
- No central venous catheter available for continuous infusion of amidoarone
- Thyroid disease under treatment
- History of cardiac conduction disorders, not treated by permanent pacemaker
- Any contra indication to amiodarone treatment
See the full eligibility criteria
- Patient aged ≥ 18 years
- Admitted in intensive care unit
- Out-of-hospital cardiac arrest with initial shockable rhythm
- Presumed cardiac or unknown cause
- Delay between ROSC and screening for randomisation \< 6 hours
- Informed consent from the patient or a surrogate or deferred consent
- Affiliated to or benefiting from a social insurance
- Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
- Indication for amiodarone decided by the physician at ICU admission
- No central venous catheter available for continuous infusion of amidoarone
- Thyroid disease under treatment
- History of cardiac conduction disorders, not treated by permanent pacemaker
- Any contra indication to amiodarone treatment
- Refractory ventricular arrhythmia or electrical storm
- Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
- Known limitations in therapy and Do Not Resuscitate-order
- Moribund patient due to pre-arrest history (estimated life expectancy \< 3 months)
- Pregnant or breastfeeding women
- Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
- Patient with known pulmonary fibrosis
- Patient with known interstitial lung disease
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Annecy, France
- Argenteuil, France
- Aurillac, France
- Brest, France
- Brive-la-Gaillarde, France
- Caen, France
- Charleville-Mézières, France
- Corbeil-Essonnes, France
- La Roche-sur-Yon, France
- La Rochelle, France
- Lyon, France
- Marseille, France
- Massy, France
- Montreuil, France
- Mulhouse, France
- Nantes, France
- Neuilly-sur-Seine, France
- Nice, France
+ 7 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Annecy, France; Argenteuil, France; Aurillac, France; Brest, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.