Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 19, 2017

Primary Completion Date

February 1, 2019

Study Completion Date

April 1, 2019

Conditions
Atrial FibrillationLung Transplant; Complications
Interventions
DRUG

Amiodarone with CoSeal

CoSeal Surgical Sealant (Baxter Healthcare) consist of 2 formulations of synthetic polyethylene glycols, a dilute hydrogen chloride solution along with a sodium phosphate/sodium carbonate solution. These separate solutions are mixed at the time of application to form a hydrogel. Amiodarone hydrochloride powder (1mg/kg) will be mixed with CoSeal at the time of application to form an amiodarone containing hydrogel. The dosing of amiodarone is based on previous study using amiodarone hydrogel in post-operative coronary artery bypass patients \[8\]. This hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.

DEVICE

CO2 driver

The amiodarone hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.

Trial Locations (1)

40202

Jewish Hospital, Louisville

All Listed Sponsors
lead

University of Louisville

OTHER

NCT03221764 - Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients | Biotech Hunter | Biotech Hunter