The effect of perioperative Dexmedetomidine on renal function in patients undergoing CABG surgery and cardiopulmonary bypass
Design
Double blinded randomized clinical trial
Settings and conduct
Patients in the dexmedmotidine group received doses of dexmedmotidine infusion at a dose of 0.5 micrograms / kg / h after induction of anesthesia until transmitted to ICU.Patients in the control group received normal saline infusion of the same volume in the intervention group after induction of anesthesia until transmitted to ICU.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age less than 70 years Patients undergoing coronary artery bypass graft surgery
Exclusion criteria:Emergency Surgery Redo Surgery Performing a coronary artery bypass graft surgery with other cardiac surgery Preoperative renal problems and serum creatinine levels higher than 1.4 Ejection fraction less than 40% Known liver problems or high levels of liver enzymes Using balloon pump inside aorta.
Intervention groups
Patients in the dexmedmotidine group received doses of dexmedmotidine infusion at a dose of 0.5 micrograms / kg / h after induction of anesthesia until transmitted to ICU.Patients in the control group received normal saline infusion of the same volume in the intervention group after induction of anesthesia until transmitted to ICU.
The effect of perioperative Dexmedetomidine on renal function in patients undergoing CABG surgery and cardiopulmonary bypass
Public title
The effect of perioperative Dexmedetomidine on renal function in patients undergoing CABG surgery and cardiopulmonary bypass
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 70 years
Patients undergoing coronary artery bypass graft surgery
Exclusion criteria:
Emergency Surgery
Redo Surgery
Performing a coronary artery bypass graft surgery with other cardiac surgery
Preoperative renal problems and serum creatinine levels higher than 1.4
Ejection fraction less than 40%
Known liver problems or high levels of liver enzymes
Using balloon pump inside aorta.
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned into two groups of intervention and control using the randomized table which is drives from randomozation.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
Dexmedetomidine and placebo are being prepared by an anesthetist who is not involved in the next stages of the study.
Placebo
Used
Assignment
Parallel
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
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-03-31, 1398/01/11
Ethics committee reference number
IR.SUMS.REC.1398.015
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Grafting surgery and cardiopulmonary bypass
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Serum creatinine level
Timepoint
Before surgery, on the first, second and third days after surgery in ICU
Method of measurement
Blood sample
2
Description
Blood Urea Nitrogen
Timepoint
Before surgery, on the first, second and third days after surgery in ICU
Method of measurement
Blood sample
3
Description
Glomerular filtration rate
Timepoint
Before surgery, on the first, second and third days after surgery in ICU
Method of measurement
Cockcroft-Gault Equation Formula
Secondary outcomes
1
Description
Inotropic Consumption in ICU
Timepoint
Before surgery, on the first, second and third days after surgery in ICU
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Patients in the dexmedmotidine group received doses of dexmedmotidine infusion at a dose of 0.5 micrograms / kg / h after induction of anesthesia until transmitted to ICU.
Category
Prevention
2
Description
Control group: Control group: Patients in the control group received normal saline infusion of the same volume in the intervention group after induction of anesthesia until transmitted to ICU.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Rahim Hemati
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
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
Hamid Reza Lotfi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Unit 4 No. 2, 19th Samaneh St, Ferdowsi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197969657
Phone
+98 51 3763 6108
Fax
Email
hamidreza1368lotfi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mansoor Masjedi
Position
Cardiac Surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
9197969658
Phone
+98 71 3647 4270
Email
Janatim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available