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After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. Several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. Nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. A tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. This study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. This is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Patients randomized to amiodarone treatment |
|
| Control Arm | Placebo Comparator | Patients randomized to placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug | Patients will undergo one of the two regimens of amiodarone, based on their ability to tolerate po (per os) intake in the post-operative period: • All patient will receive 1050mg of amiodarone in 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:
|
| Measure | Description | Time Frame |
|---|---|---|
| Capability for enrolment | Capacity for enrolment will be assessed, in order to determine recruitment potential and an optimal sample size estimated for a full-scale RCT, by measuring the following outcomes: proportion of patients risk stratified and screened, proportion of eligible individuals consenting to involvement in the study, proportion of recruited individuals who are enrolled in the study. | Upon study completion, 1 year following study initiation |
| Proportion of patients randomized who receive the intervention | Feasibility of the randomization process will be evaluated including the proportion of patients randomized who receive the intervention | Upon study completion, 1 year following study initiation |
| Knowledge of which patients received intervention and placebo | Feasibility of blinding of participant, care provider, investigator, and outcomes assessor to the intervention allocation of participants will be evaluated by administering a survey to assess their knowledge of which patients received the intervention and placebo | Upon study completion, 1 year following study initiation |
| Intervention delivery | Intervention delivery will be assessed by determining if protocol adherence rates exceed >90% and recording observational data on the quality of intervention delivery using a data collection sheet | Upon study completion, 1 year following study initiation |
| Protocol compliance | Monitoring of protocol compliance will be measured by the frequency, rate, and rationale of events when study activities diverge from the REB-approved protocol | Upon study completion, 1 year following study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative atrial fibrillation | Incidence of postoperative atrial fibrillation, as defined by atrial fibrillation proved by electrocardiogram with an irregular narrow complex tachycardia without p waves | Within 30 days post-surgery |
| Severity of postoperative atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew JE Seely, MD, PhD | Contact | 613-737-8899 | 74052 | aseely@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andrew JE Seely, MD, PhD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34098992 | Derived | Smith HA, Kanji S, Tran DTT, Redpath C, Ferguson D, Lenet T, Sigler G, Gilbert S, Maziak D, Villeneuve P, Sundaresan S, Seely AJE. Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study. Trials. 2021 Jun 7;22(1):384. doi: 10.1186/s13063-021-05318-1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2024 | |
| Reset | Oct 4, 2024 | |
| Release | Jan 16, 2025 | |
| Reset | Feb 6, 2025 | |
| Release | Apr 22, 2025 | |
| Reset | May 7, 2025 | |
| Release | Jun 23, 2025 | |
| Reset | Jul 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2024 | Oct 4, 2024 | |||
| Jan 16, 2025 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Prospective, single-centre, double arm pragmatic randomized controlled feasibility trial
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|
| Placebo | Drug | Patients will undergo one of the two schedules or intravenous infusion, based on their ability to tolerate po intake in the post-operative period:
|
|
| Adherence to safety protocol | Monitoring of safety will be assessed by determining the rate and efficiency of reporting adverse events if they occur and monitoring adherence rates to safety and monitoring protocols | Upon study completion, 1 year following study initiation |
| Proportion of patients for which data could be abstracted | Feasibility of data extraction analysis will be evaluated by the proportion of patients for which the required data could be abstracted: medication use, incidence of post-operative atrial fibrillation, post-operative outcomes, etc. | Upon study completion, 1 year following study initiation |
| Resources | Resources required to conduct a future multi-centre PREP-AF trial will be assessed by evaluating the administrative capacity of the POAF research team, including the required number of hours of research assistant time, as well as the feasibility of the designated study budget | Upon study completion, 1 year following study initiation |
Severity of postoperative atrial fibrillation, as classified by the Clavien-Dindo classification schema, defined for thoracic surgery using the published Ottawa Thoracic Morbidity and Mortality system |
| Within 30 days post-surgery |
| Hospital length of stay | Hospital length of stay, as defined as the number of days inclusive between the day of surgery, and the day of discharge | Within 30 days post-surgery |
| Other postoperative complications | Other postoperative complications using the taxonomy of the Ottawa Thoracic Morbidity and Mortality definitions. All complications are recorded with incidence, date, and severity. Of note, post-operative mortality is a grade V complication and is recorded along with its cause as well | Within 30 days post-surgery |
| Feb 6, 2025 |
| Apr 22, 2025 | May 7, 2025 |
| Jun 23, 2025 | Jul 10, 2025 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |