Authorised Therapeutic use (Phase IV) New-onset atrial fibrillation

Pharmacokinetics and pharmacodynamics of amiodarone in critically ill patients treated for atrial fibrillation - a randomised clin

EU CTIS ID: 2025-521289-88-02

What this study is testing

To examine pharmacokinetics of amiodarone by measuring concentrations of amiodarone and its active metabolite N-desethylamiodarone in blood, in bronchoalveolar lavage and in exhaled breath condensate during intravenous amiodarone (standard of care) versus interal amiodarone (intervention) in critically ill mechanically ventilated patients with new-onset atrial fibrillation.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adults (18 years of age or older)
  • Admitted to the intensive care unit
  • Treated with a single dose of intravenous amiodarone 150-300 mg for new-onset atrial fibrillation
  • Needing continuous treatment with amiodarone for new-onset atrial fibrillation
  • Invasively mechanically ventilated
  • Normal gastrointestinal function defined as uncomplicated enteral feeding with aspirate less than 300 mL per day

You likely can't join if

  • Persistent or paroxysmal atrial fibrillation treated with amiodarone prior to hospitalisation
  • Treated with amiodarone during the current hospitalisation prior to intensive care unit admission
  • Pregnancy
  • Known allergy to amiodarone
  • Under coercive measures

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.