Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- IL6 level as a proinflammatory cytokine
Study Overview
Brief Summary
Cardiopulmonary bypass (CPB) allowed the correction of several congenital heart diseases such as intracardiac malformations, but it is well known that this is not a harmless procedure because it can lead to a systemic inflammatory response syndrome (SIRS), with activation of complement, cytokines, coagulation, and fibrinolysis pathways.
Due to economic causes, hemofilters became less available in low-resource countries, which forced perfusionists to use hemodialyzers instead during CPB. Preliminary data showed the potential safety of using hemodialyzers instead of hemofilters in Zero-balanced ultrafiltration.
The Objectives of the study This study aims to compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted.
- •Age of patients from 1 year to 15 years.
- •CPB duration more than 60 minutes.
Exclusion Criteria
- •Pediatric patients with known signs of sepsis.
- •Pediatric patients having had previous cardiothoracic surgery.
- •Preoperative renal failure.
- •Preoperative cardiogenic shock requiring the use of inotropes.
- •Preoperative lactate concentration > 2 mmol/L.
Arms & Interventions
hemodialyzers
20 patients
Intervention: hemodializer (Device)
hemofilters
20 patients
Intervention: hemofilter (Device)
Outcomes
Primary Outcomes
IL6 level as a proinflammatory cytokine
Time Frame: preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).
Secondary Outcomes
- Other proinflammatory cytokine(preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).)