Back to resultsDexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery
Primary Purpose
Cardiac Surgical Procedures
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgical Procedures focused on measuring Dexmedetomidine, Congenital Heart Disease, Cardiopulmonary Bypass, Interleukin
Eligibility Criteria
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
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group D
Group S
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Infilamatory response
Interleukin 6 and 10
Secondary Outcome Measures
Sedation score
Special scale
Length of mechanical ventilaton
Length of mechanical ventilaton In days
Length of ICU stay
Length of ICU stay In days
Length of hospital stay.
Length of hospital stay days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03163238
Brief Title
Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed Description
Dexmedetomidine will be used during Cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgical Procedures
Keywords
Dexmedetomidine, Congenital Heart Disease, Cardiopulmonary Bypass, Interleukin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group S
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline 0.9
Intervention Description
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
Primary Outcome Measure Information:
Title
Infilamatory response
Description
Interleukin 6 and 10
Time Frame
Within the first 24 hours
Secondary Outcome Measure Information:
Title
Sedation score
Description
Special scale
Time Frame
Within the first 24 hours
Title
Length of mechanical ventilaton
Description
Length of mechanical ventilaton In days
Time Frame
Within 7 days
Title
Length of ICU stay
Description
Length of ICU stay In days
Time Frame
Within 7 days
Title
Length of hospital stay.
Description
Length of hospital stay days
Time Frame
Within 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sayed K Abd-Elshafy, MD
Phone
0882293592
Email
sayed_k_72@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed K Abd-Elshafy, MD
Organizational Affiliation
Associate profossor of anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed abdelatef, MD
Phone
0020882413201
Email
latif_mohamed@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery
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