Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03163238
• Other study ID #: IRB000087632
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: Sayed K Abd-Elshafy, MD
• Phone: 0882293592
• Email: sayed_k_72[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Dexmedetomidine will be used during Cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.
• Normal saline
One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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