Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients
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|ClinicalTrials.gov Identifier: NCT03221764|
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Lung Transplant; Complications||Drug: Amiodarone with CoSeal Device: CO2 driver||Phase 2|
Approximately 1900 transplants are performed in the US annually. Lung transplantation remains the gold standard treatment for patients with end stage lung disease. This includes patients with range of etiologies such as Idiopathic Pulmonary Fibrosis, COPD and Cystic Fibrosis. One of the more common post-operative complications in patients undergoing lung transplantation is the development of atrial fibrillation. Recent studies have demonstrated that approximately 1/3 of patients will develop atrial fibrillation during their post-operative course. While it is uncertain if the development of post-operative atrial fibrillation affects survival, it does significantly increase length of hospital stay. Importantly, a portion of the patients that develop atrial fibrillation post-operatively will require cardioversion prior to discharge.
Currently one of the main stays of treatment for post-operative atrial fibrillation is systemic (oral or intravenous) amiodarone, which is a class III antiarrhythmic agent. While this particular drug is effective, it does carry the risk of several known complications. Due to the drug's pharmacokinetics, amiodarone concentrates in organs with high lipid content such as the thyroid, liver and lung. Amiodarone has several known adverse effects on the lung ranging from acute respiratory distress syndrome to more chronic disease such as Interstitial pulmonary fibrosis. Amiodarone can have detrimental effects on the liver which in rare cases could lead to cirrhosis. Additionally, amiodarone can cause thyrotoxicosis as early as a few weeks after the initiation of amiodarone.
The adverse events listed above are related to the cumulative dose of amiodarone. Typically, when amiodarone is initiated, patients receive a loading dose of 600-800mg daily until the cumulative dose reaches 10 grams, after which patients will receive 200mg daily as a maintenance dose. Minimizing the cumulative dose of amiodarone by using a local application, could mitigate the potential adverse drug toxicities. In a previous study, the application of an amiodarone releasing hydrogel performed intraoperatively was shown to significantly decrease the rates of post-operative atrial fibrillation in patients undergoing coronary artery bypass. Currently for patients undergoing lung transplantation, there is not a safe and effective measure available to prevent post-operative atrial fibrillation.
The Investigators aim to study the intraoperative application of an amiodarone containing hydrogel for prevention of post-operative atrial fibrillation in lung transplant patients.
In patients undergoing lung transplantation, post-operative atrial fibrillation is common and leads to prolonged hospital course and increased healthcare expenditures. Amiodarone is a main stay of therapy for atrial fibrillation, however this drug does have potential serious complications when administered systemically. The local application of amiodarone, could potentially decrease the rates of atrial fibrillation, while avoiding the systemic complications. This has the potential to decrease length of stay and decrease additional procedures (ie. Cardioversion) in patients undergoing lung transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Intra-Operative Application of Amiodarone Releasing Hydrogel to Prevent Postoperative Atrial Fibrillation in Patients Undergoing Lung Transplantation|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: Amiodarone with CoSeal administered with CO2 driver
Lung Transplant Recipients who receive Intraoperative application of an Amiodarone containing hydrogel at the time of transplant.
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 . This hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.
Other Name: Amiodarone with CoSealadministered with CO2 driver
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.
- Number of patients developing atrial fibrillation after lung transplant [ Time Frame: Patients will be monitored for up to one year following lung transplant ]Patients will be continuously on monitored via telemetry for development of atrial arrhythmias during their post-operative hospital stay
- Length of hospital stay after transplant [ Time Frame: From transplant to discharge from hospital, up to 1 year ]Assessing length of stay in hospital after lung transplant - measured from time of transplant until initial discharge from hospital
- 30 Day Survival [ Time Frame: 30 Day ]Survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221764
|Contact: Victor H van Berkel, MD, PHDfirstname.lastname@example.org|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|Contact: Victor van Berkel, MD, PhD 502-588-7600 email@example.com|
|Principal Investigator: Victor van Berkel, MD, PhD|
|Sub-Investigator: Matthew Fox, MD|
|Sub-Investigator: William Whited, MD|
|Principal Investigator:||Victor H van Berkel, MD, PHD||University of Louisville|