Compare the Impact of Hemofilters and Hemodialyzers on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery

Alnas Hospital60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cardio-pulmonary Bypass Cytokine

Interventions

Eligibility

Sex: ALLMax age: 15 Years

Medical Language ↔ Plain English

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.

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

IL1β, Lactate level