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

Key facts

Where
Aalborg, DániaSee the site
Phase
4. fázis

Where in Dánia

  • Aalborg University HospitalAalborg, DániaTaking people

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Trial details

Who runs it
Aalborg University Hospital
Trial code
EU 2025-521289-88-02
Record updated
2026. május 28.
Original description
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.Read full original descriptionShow less

Pharmacokinetics and pharmacodynamics of intravenous versus enteral amiodarone in critically ill patients with new-onset atrial fibrillation – a randomised controlled pilot trial

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.

Inclusion: 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.

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

EU CTIS 2025-521289-88-02