Cardiac Surgical Procedures Clinical Trial
Official title:
The Effect of Dexmedetomidine on the Inflammatory Response in Children Under Congenital Heart Disease Repair With Cardiopulmonary Bypass: A Randomized Controlled Clinical Trial
Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more severe clinical condition. Inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 12 Years |
Eligibility | Inclusion Elective repair of congenital heart disease with cardiopulmonary bypass Exclusion Reintervention surgery requirement for blood products from the start of CPB, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infilamatory response | Interleukin 6 and 10 | Within the first 24 hours | |
Secondary | Sedation score | Special scale | Within the first 24 hours | |
Secondary | Length of mechanical ventilaton | Length of mechanical ventilaton In days | Within 7 days | |
Secondary | Length of ICU stay | Length of ICU stay In days | Within 7 days | |
Secondary | Length of hospital stay. | Length of hospital stay days | Within 7 days |
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