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The investigators will be comparing two different filtration methods on cardiopulmonary bypass for pediatric heart surgery patients. Three blood tests will be taken from the patient to compare which filtration method is better at decreasing post-cardiopulmonary bypass inflammation caused by the heart-lung machine.
The study holds promise to evaluate the efficacy of dilutional ultrafiltration (DUF) compared to the currently utilized conventional ultrafiltration method in a prospective randomized controlled trial. A disposable hemoconcentrator is included in the cardiopulmonary bypass circuit which allows for removal of plasma water and solutes with a molecular weight below 65,000 Daltons. Alternatively, dilutional ultrafiltration (DUF) is a process during cardiopulmonary bypass that uses a hemoconcentrator to remove effluent containing inflammatory mediators but also return equal amounts of Plasmalyte to the patient's blood volume through the cardiopulmonary bypass circuit. Plasmalyte is a balanced crystalloid solution that has a similar concentration of electrolytes, osmolality, and pH to human plasma. The "dilutional effect" in DUF is caused by adding Plasmalyte and reducing inflammatory mediators in a patient's entire blood volume while also replacing necessary electrolytes lost during ultrafiltration. The purpose of this study is to examine plasma C-Reactive Protein levels pre-bypass, 12 hours post-bypass, and 24 hours post-bypass comparing the two filtration methods to discover if there is a measurable decrease in postoperative inflammation using dilutional ultrafiltration (DUF) compared to conventional ultrafiltration (CUF). The primary objective of this trial is to evaluate the efficacy of dilutional ultrafiltration (DUF) compared to conventional ultrafiltration (CUF) on cardiopulmonary bypass patients by measuring the outcome of C-Reactive Protein (CRP). The secondary objective is to track postoperative clinical measurements associated with inflammation such as postoperative fluid balance, alveolar arterial gradient, inotrope score, diuretic need, time to negative fluid balance, postoperative length of intubation, and length of ICU stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional ultrafiltration Group | Conventional ultrafiltration will only have excess effluent removed during cardiopulmonary bypass. | ||
| Dilutional ultrafiltration Group | Dilutional ultrafiltration will have continuous removal of effluent and replacement of this fluid with Plasmalyte. |
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| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive Protein outcome measure concentration in mg/dL | Measure of acute inflammation in the body | Baseline measurement |
| C-Reactive Protein concentration in mg/dL | Measure of acute inflammation in the body | 12 hours post-bypass |
| C-Reactive Protein concentration measured in mg/dL | Measure of acute inflammation in the body | 24 hours post-bypass |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having cardiac surgery with cardiopulmonary bypass who meet inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsey N Stuhm, Cardiovascular Perfusion | Contact | 3305438536 | lstuhm@akronchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Lindsey N Stuhm, MSHS CCP | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
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| Label | URL |
|---|---|
| Modified and conventional ultrafiltration during pediatric cardiac surgery: clinical outcomes compared. | View source |
| Effects of dilutional and modified ultrafiltration in plasma endothelin-1 and pulmonary vascular resistance after the Fontan procedure | View source |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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Blood sample retained for plasma testing.
| Effect of modified ultrafiltration in high-risk patients undergoing operations for congenital heart disease. |
| View source |
| Hemofiltration increases IL-6 clearance in early systemic inflammatory response syndrome but does not alter IL-6 and TNF alpha plasma concentrations. | View source |
| Hemofiltration during cardiopulmonary bypass | View source |
| Role of C-Reactive Protein at Sites of Inflammation and Infection. | View source |