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Comparing Filtration Methods in Pediatric Heart Surgery

This study is looking at two different ways to filter blood during heart surgery in children who are on a heart-lung machine (cardiopulmonary bypass or CPB). The two methods are called conventional ultrafiltration and dilutional ultrafiltration. Researchers want to see which method is better at reducing inflammation after surgery. They will measure a substance in the blood called C-Reactive Protein (CRP), which is a marker of inflammation, at three different times: before surgery, 12 hours after surgery, and 24 hours after surgery. This study is for children between 1 day and 5 years old who are having heart surgery using a heart-lung machine. You cannot join if you are older than 5 or have another illness that would already raise your CRP levels. The study is currently observational, meaning researchers are watching and collecting information, and the status of recruitment is unclear.

Study design
This is an observational study comparing two filtration methods during pediatric heart surgery, with a planned enrollment of 100 participants.
What's involved
You would have three blood tests: one before surgery, one 12 hours after bypass, and one 24 hours after bypass.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 hours post-bypass for C-Reactive Protein measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221630

Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients

Not Yet Recruiting
Not specifiedAges 1–5Observational
Akron Children's Hospital
~100 participants
Updated 2025-10-28 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
C-Reactive Protein outcome measure concentration in mg/dL
Measured over Baseline measurement
+2 more outcomes measured

Conditions

Systemic Inflammatory Response Syndrome

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NCT07221630

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Akron Children's Hospital

    Akron, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lindsey N Stuhm, MSHS CCP · PRINCIPAL_INVESTIGATOR · Akron Children's Hospital

Who to contact

Lindsey N Stuhm, Cardiovascular Perfusion
[email protected]
3305438536
Email the study team

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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

What this trial measures

  • C-Reactive Protein outcome measure concentration in mg/dLBaseline measurement

    Measure of acute inflammation in the body

  • C-Reactive Protein concentration in mg/dL12 hours post-bypass

    Measure of acute inflammation in the body

  • C-Reactive Protein concentration measured in mg/dL24 hours post-bypass

    Measure of acute inflammation in the body