Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients

NCT07221630 | Not Yet Recruiting DMC

• 1 other identifier: AkronCH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 filtration method is better at decreasing post-cardiopulmonary bypass inflammation caused by the heart-lung machine.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Dilutional Ultrafiltration; Conventional Ultrafiltration; Cardiopulmonary Bypass; C-reactive protein

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients having cardiac surgery with cardiopulmonary bypass who meet inclusion criteria.

You may qualify if:

• Males and females less than 5 years of age
• Cardiac operations utilizing CPB
• Cardiac reoperations utilizing CPB

You may not qualify if:

• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Links

• Modified and conventional ultrafiltration during pediatric cardiac surgery: clinical outcomes compared.
• Effects of dilutional and modified ultrafiltration in plasma endothelin-1 and pulmonary vascular resistance after the Fontan procedure
• Effect of modified ultrafiltration in high-risk patients undergoing operations for congenital heart disease.
• Hemofiltration increases IL-6 clearance in early systemic inflammatory response syndrome but does not alter IL-6 and TNF alpha plasma concentrations.
• Hemofiltration during cardiopulmonary bypass
• Role of C-Reactive Protein at Sites of Inflammation and Infection.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample retained for plasma testing.

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Lindsey N Stuhm, MSHS CCP

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey N Stuhm, Cardiovascular Perfusion

CONTACT

3305438536; lstuhm@akronchildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Certified Clinical Perfusionist

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 2, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)