Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients (NCT07221630) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients
United States100 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
1 Day – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females less than 5 years of age
* Cardiac operations utilizing CPB
* Cardiac reoperations utilizing CPB
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
C-Reactive Protein outcome measure concentration in mg/dL
Timeframe: Baseline measurement
2
C-Reactive Protein concentration in mg/dL
Timeframe: 12 hours post-bypass
3
C-Reactive Protein concentration measured in mg/dL