Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Inflammatory Response Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lindsey N Stuhm, Cardiovascular Perfusion; Phone Number: 3305438536; Email: lstuhm@akronchildrens.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Akron Children's Hospital
• Investigators: Principal Investigator: Lindsey N Stuhm, MSHS CCP, Akron Children's Hospital

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 2, 2027

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Estimated): October 28, 2025

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; C-reactive protein; Dilutional Ultrafiltration; Conventional Ultrafiltration
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: AkronCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No