2025-521289-88-02RecruitingPhase 4
Pharmacokinetics and pharmacodynamics of amiodarone in critically ill patients treated for atrial fibrillation - a randomised clin
Pharmacokinetics and pharmacodynamics of intravenous versus enteral amiodarone in critically ill patients with new-onset atrial fibrillation – a randomised controlled pilot trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 May 2025
- Start date
- 1 Sept 2025
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Atrial fibrillation
- EU CT number
- 2025-521289-88-02
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent or paroxysmal atrial fibrillation treated with amiodarone prior to hospitalisation
- Treated with amiodarone during the current hospitalisation prior to intensive care unit admission
Other illness
- Known allergy to amiodarone
Other
- Pregnancy
- Under coercive measures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.