Tests two ways of giving amiodarone to critically ill patients with new atrial fibrillation
Compares intravenous and enteral amiodarone levels in critically ill adults with new atrial fibrillation.
Key facts
- Who runs it
- Aalborg University Hospital
- Where
- Aalborg, DenmarkSee the site
- Trial code
- Registry title
- Pharmacokinetics and pharmacodynamics of amiodarone in critically ill patients treated for atrial fibrillation - a randomised clin
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 50 people, planned
- Started
- 1 Sept 2025
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional
- Record updated
- 28 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in intensive care on a breathing machine who have new-onset atrial fibrillation and need amiodarone treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- New-onset atrial fibrillation, needing continuous amiodarone treatment, in intensive care with invasive mechanical ventilation
- Earlier treatment
- Must have had a single dose of intravenous amiodarone 150-300 mg for the new atrial fibrillation. Must not have had amiodarone for atrial fibrillation before hospital admission or before intensive care admission.
Main reasons for not taking part
- Persistent or paroxysmal atrial fibrillation treated with amiodarone before hospitalisation
- Amiodarone given during this hospital stay before intensive care admission
- Pregnancy
- Known allergy to amiodarone
- Under coercive measures
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Pharmacokinetics and pharmacodynamics of intravenous versus enteral amiodarone in critically ill patients with new-onset atrial fibrillation – a randomised controlled pilot trial
- Plain-language title
- Tests two ways of giving amiodarone to critically ill patients with new atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 May 2026