Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

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

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgical Procedures
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal saline

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sayed K Abd-Elshafy, MD; Phone Number: 0882293592; Email: sayed_k_72@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group D; One syringe contain 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.	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.; Other Names: Precedex
PLACEBO_COMPARATOR: Group S; 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	Drug: 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; Other Names: Saline 0.9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infilamatory response	Interleukin 6 and 10	Within the first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation score	Special scale	Within the first 24 hours
Length of mechanical ventilaton	Length of mechanical ventilaton In days	Within 7 days
Length of ICU stay	Length of ICU stay In days	Within 7 days
Length of hospital stay.	Length of hospital stay days	Within 7 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2017
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Dexmedetomidine; Cardiopulmonary Bypass; Interleukin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: IRB000087632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No