The effect of preoperative dexmedetomidine use and acute kidney injury in pediatric patients with congenital heart disease undergoing open cardiac surgery
Objective: The effect of perioperative dexmedetomidine use and acute kidney injury in pediatric patients with congenital heart disease undergoing open cardiac surgery .
Design
Study design: Double blind randomized clinical trial.
Settings and conduct
Intervention: After inserting the central venous catheter, the blood sample is sent to the laboratory for evaluation of serum creatinine.
In the group (D), 0.4 μg / kg / hr. of dexmedetomidine infusion were administered after anesthesia induction until the end of the operation. In the control group (C)the same volume of normal saline will be administered, which continues until the end of the operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 70 children aged 6 months to 8 years with congenital heart disease who are candidates for open heart surgery.
Exclusion Criteria: Emergency surgery, re-operation (re-do), heart failure, preoperative renal failure (Serum Cr> 2 mg / dl), liver failure, use of inotropic or vasopressor prior to surgery, need Deep hypothermic circulatory arrest during surgery
Intervention groups
Intervention: After inserting the central venous catheter, the blood sample is sent to the laboratory for evaluation of serum creatinine.
In the group (D), 0.4 μg / kg / hr. of dexmedetomidine infusion were administered after anesthesia induction until the end of the operation. In the control group (C)the same volume of normal saline will be administered, which continues until the end of the operation.
Main outcome variables
The serum level of creatinine, GFR: Glomerular filtration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130816014372N10
Registration date:2019-04-26, 1398/02/06
Registration timing:prospective
Last update:2019-04-26, 1398/02/06
Update count:0
Registration date
2019-04-26, 1398/02/06
Registrant information
Name
Simin Azemati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
azemati@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-25, 1398/03/04
Expected recruitment end date
2019-07-26, 1398/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative dexmedetomidine use and acute kidney injury in pediatric patients with congenital heart disease undergoing open cardiac surgery
Public title
The effect of preoperative dexmedetomidine use and acute kidney injury in pediatric patients with congenital heart disease undergoing open cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 6 months to 8 years
congenital heart disease
Children who are candidates for open heart surgery
Exclusion criteria:
Emergency operation
Re-do Operation
heart failure
preoperative renal failure (Serum Cr> 2 mg / dl
Liver failure
Use of inotropic or vasopressor prior to surgery
Need Deep hypothermic circulatory arrest during surgery
Age
From 6 months old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Dexmedetumidine and normal saline are prepared by an anesthesia nurse who is not involved in the study and will provide to the researcher with a randomized table.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
Intervention group: In the group (D), 0.4 μg / kg / hr. of dexmedetomidine infusion were administered after anesthesia induction until the end of the operation.
Category
Prevention
2
Description
Control group: In the control group (C) same volume of normal saline will be administered, which continues until the end of the operation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
khalili Hospital
Full name of responsible person
Sheema Eskandari
Street address
khalili Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134842119
Phone
+98 71 3647 4270
Email
namazi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sheema Eskandari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 36474270
Email
eskandari.sheema@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Simin Azemati
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 36474270
Email
azemati@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Simin Azemati
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 36474270
Email
azemati@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available