Cardiac Surgery
Conditions
Brief summary
Single blind feasibility trial using a binary 'traffic light' design to evaluate the feasibility of injecting normal physiological saline into the atria of patients at the time of clinically indicated open chest cardiac surgery.
Detailed description
In this project, The investigators will see if patients can undergo successful transepicardial injection of saline at the time of cardiac surgery as compared to no injection. Patients will be randomised in a 1:1 allocation ratio using a parallel two-arm design. The study is designed to meet the following 3 feasibility objectives before proceeding: reasonable recruitment uptake, successful transepicardial injection of saline into the atria, and adequate retention of patients at follow-up.
Interventions
DRUGnormal saline
Once the patient is placed on cardiopulmonary bypass, the product will be injected into the left atrial wall using a 27 gauge needle as 4 injections of 200 μL each. Two will be placed in the atrial appendage. The remaining 2 injections will be placed equidistant on the anterior atrial free wall. Each injection will be performed just under the surface of the atrial epicardium over 30 seconds. The needle will stay in place for 10 seconds after the injection to limit back flow from the site of injection.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.
Exclusion criteria
1. Age less than or equal to 18 years of age. 2. Pregnant or breast feeding. 3. Patient is unable or unwilling to provide informed consent. 4. Patient is included in another randomized clinical trial. 5. A history of complex congenital heart disease. 6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years. 7. Underwent ineligible procedures during or prior to operation (including atrial fibrillation ablation, heart transplantation, pulmonary thromboendarterectomy, isolated thoracic aorta procedures, ventricular assist device insertion, extracorporeal membrane oxygenator insertion, and percutaneous valve replacement). 8. Patients for whom the investigator believes that the trial is not in the interest of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment fidelity | 1 year | Treatment successfully applied \< 50% (approach not feasible), 50-75% (approach needs to be revised) and \> 75% (approach is feasible). |
| Participant retention (follow up) | 30 days post surgery | Follow up: \< 65% (project not feasible), 65-85% (follow-up needs to be revised), \> 85% (project is feasible). |
| Recruitment uptake | 1 year | Recruitment uptake \<20% (project not feasible), 20-35% (protocol needs to be revised), and \> 35% (project feasible). |
Countries
Canada
Outcome results
None listed