NCT07221630

Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients

Effects of Conventional and Dilutional Ultrafiltration Techniques During Cardiopulmonary Bypass in Pediatric Cardiac Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Akron Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 5 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Systemic Inflammatory Response Syndrome

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-01-02
• First posted: 2025-10-28
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States