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Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03221764
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Victor Van Berkel, University of Louisville

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Lung Transplant; Complications Drug: Amiodarone with CoSeal Device: CO2 driver Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 [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.
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 30 Day Survival [ Time Frame: 30 Day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject or legal representative has signed Informed Consent Form (ICF)
  • Undergoing lung transplant at the Jewish Hospital
  • Age ≥ 18 years
  • Subjects willing and able to comply with the follow up requirements of the study

Exclusion Criteria:

  • Patients with previous history of atrial fibrillation.
  • Patients with previously documented allergy or adverse reaction to amiodarone.
  • Patients with previous ablation for atrial fibrillation
  • Patients with an implantable pacemaker.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03221764

Contact: Victor H van Berkel, MD, PHD 5025887601

United States, Kentucky
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Victor van Berkel, MD, PhD    502-588-7600   
Principal Investigator: Victor van Berkel, MD, PhD         
Sub-Investigator: Matthew Fox, MD         
Sub-Investigator: William Whited, MD         
Sponsors and Collaborators
University of Louisville
Principal Investigator: Victor H van Berkel, MD, PHD University of Louisville

Responsible Party: Victor Van Berkel, Assistant Professor, University of Louisville Identifier: NCT03221764     History of Changes
Other Study ID Numbers: 16.1213
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors