AMIODARONE HYDROCHLORIDE for New-onset atrial fibrillation

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Pharmacokinetic of amiodarone","definition_or_measurement_approach":"Measuring concentrations of amiodarone and its active metabolite N-desethylamiodarone in blood, in bronchoalveolar lavage and in exhaled breath condensate."}

Secondary endpoints

• {"endpoint_text":"- Pharmacodynamics of amiodarone","definition_or_measurement_approach":"Measured by conversion to sinus rhythm, oxygenation, proteomics in bronchoalveolar lavage, days alive without life-support (invasive mechanical ventilation, vasopressors, dialysis), inflammatory markers (C-reactive protein and leucocytes) and liver enzymes in blood, and ICU mortality within 10 days after initiating treatment."}

Other endpoints

• {"endpoint_text":"- To examine if concentrations of amiodarone and N-desethylamiodarone in exhaled breath condensate are equal to concentrations in brochoalveolar lavage.","definition_or_measurement_approach":"Compare concentrations of amiodarone and N-desethylamiodarone measured in exhaled breath condensate with concentrations measured in bronchoalveolar lavage."}
• {"endpoint_text":"- To examine if proteomics analyses in exhaled breath condensate are equal to proteomics in bronchoalveolar lavage.","definition_or_measurement_approach":"Compare proteomics profiles from exhaled breath condensate and bronchoalveolar lavage samples."}

Denmark

Earliest CTIS Part Ii Submission Date

02-06-2025

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Aalborg University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}