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Conventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients

ConditionSystemic Inflammatory Response Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorAkron Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females less than 5 years of age

Cardiac operations utilizing CPB

Cardiac reoperations utilizing CPB

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Conventional ultrafiltration Group
Group B: Dilutional ultrafiltration Group

Trial outcomes

Primary outcomes

1

C-Reactive Protein outcome measure concentration in mg/dL

Measure of acute inflammation in the body

Time frame
Baseline measurement
2

C-Reactive Protein concentration in mg/dL

Measure of acute inflammation in the body

Time frame
12 hours post-bypass
3

C-Reactive Protein concentration measured in mg/dL

Measure of acute inflammation in the body

Time frame
24 hours post-bypass

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akron Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: