drugset / Trial / NCT03221764

Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

NCT03221764

Phase 2 Completed 20 enrolled University of Louisville
NaSingle-groupOpen-labelTreatment

Summary

This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to the pulmonary veins and atria at the time of lung transplantation. This study will include patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective group will be compared to historical controls from the same institution. Investigators will access medical records and database entries for those patients undergoing lung transplantation after January 1st 2005 in order to obtain matched controls for analysis. Informed consent will be obtained from the prospective cohort prior to patient enrollment. This pilot study will be used to obtain preliminary data in order to proceed with a larger randomized control trial.

Timeline

Start
2017-10-19
Primary completion
2019-02-01
Completion
2019-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiodarone Small molecule 1 mg/kg Other

Indications