Cardio-pulmonary Bypass, Cytokine
Conditions
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.
Interventions
DEVICEhemodializer
Fresenius Helixone FX5 (61346 Bad Homburg, Germany)
DEVICEhemofilter
Medica (741036 Medolla, Italy)
Sponsors
Alnas Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted. 2. Age of patients from 1 year to 15 years. 3. CPB duration more than 60 minutes.
Exclusion criteria
1. Pediatric patients with known signs of sepsis. 2. Pediatric patients having had previous cardiothoracic surgery. 3. Preoperative renal failure. 4. Preoperative cardiogenic shock requiring the use of inotropes. 5. Preoperative lactate concentration > 2 mmol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL6 level as a 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | IL1β, Lactate level |
Countries
Egypt
Outcome results
None listed