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Logistical issues
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline injection | Experimental | After the patient is placed on cardiopulmonary bypass, the surgeon will inject a saline into the atria. |
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| standard of care | No Intervention | The patient will be placed on cardiopulmonary bypass as usual and the surgery will proceed without an attempt to inject saline into the atrial tissue. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment uptake | Recruitment uptake <20% (project not feasible), 20-35% (protocol needs to be revised), and > 35% (project feasible). | 1 year |
| Treatment fidelity | Treatment successfully applied < 50% (approach not feasible), 50-75% (approach needs to be revised) and > 75% (approach is feasible). | 1 year |
| Participant retention (follow up) | Follow up: < 65% (project not feasible), 65-85% (follow-up needs to be revised), > 85% (project is feasible). | 30 days post surgery |
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Inclusion Criteria:
Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darryl Davis | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Insitute | Ottawa | Ontario | K1Y4W7 | Canada |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |