Status:
NOT_YET_RECRUITING
Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients
Lead Sponsor:
Akron Children's Hospital
Conditions:
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
1-5 years
Brief 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 f...
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...
Eligibility Criteria
Inclusion
- Males and females less than 5 years of age
- Cardiac operations utilizing CPB
- Cardiac reoperations utilizing CPB
Exclusion
- Patients greater than 5 years of age.
- Any active SYSTEMIC noncardiac disease expected to raise patient baseline CRP levels to above normal levels (\>1mg/dL). Since CRP levels correlate with the severity of most skin disease, patients with active dermatitis issues on the day of surgery will be excluded from the study. Patients with autoimmune diseases including RA, SLE, IBD (Crohn's disease, ulcerative colitis), Kawasaki disease and patients experiencing active infections will be excluded from the study.
- Any noncardiac disease not well controlled (ex. Asthma not properly controlled with medication, etc.)
- Recent viral illness (ex. Positive COVID/flu test 30 days prior to surgery)
- All patients receive solumedrol (10mg/kg dose) from anesthesia as part of the prebypass protocol. Any patient currently taking steroids will also be excluded from the study
- Non-cardiopulmonary bypass cases (Off pump CoA, Vascular ring surgery, etc.)
- ECMO patients
- Emergent cases
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 2 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07221630
Start Date
January 1 2026
End Date
January 2 2027
Last Update
October 28 2025
Active Locations (1)
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1
Akron Children's Hospital
Akron, Ohio, United States, 44308