50 patients will be randomly assigned into treatment and placebo control group. They will receive standard care and intervention for kidney transplantation in our setting. Treatment group will receive 1 mcg/kg/hr of the dexmedetomidine infusion and the placebo group will receive the same volume of normal saline. Demographic information, clinical examination, patients's history and blood chemistry parameters will be recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101331487N5
Registration date:2017-10-24, 1396/08/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of dexmedetomidine infusion during surgery on renal function parameters in patients receiving kidney transplantation
Public title
Drug therapy for improving the renal function after kidney transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
- end stage renal disease (ESRD) patients
- candidate for renal transplant
- graft from living donor
- age from 18 to 70 years old
Exclusion criteria:
- bradycardia (HR<50)
- hypotension (SBP<100)
- ejection fraction below 30% (EF<30%)
- transplant from cadaver
- simultaneous transplantation of kidney and pancreas
- having contraindication for kidney transplantation
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
15459-13487
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311174023
Health conditions studied
1
Description of health condition studied
End-stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Glomerular filtration rate
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Biochemistry analyzer
2
Description
Creatinine
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Biochemistry analyzer
3
Description
Urea
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Biochemistry analyzer
4
Description
Sodium
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Biochemistry analyzer
5
Description
Hemoglobin
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Hematology analyzer
6
Description
Hematocrit
Timepoint
After patients transfer to ICU, then every one hours until 6 hours after transfer to ICU, then every two hours until 24 hours after ICU and then every 6 hours until the time of discharge
Method of measurement
Hematology analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Control
Category
Placebo
2
Description
Dexmedetomidine infusion with dose of 1 mcg/kg/hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nejad Urology Hospital
Full name of responsible person
Dr Mehrdad Mesbah Kiaee
Street address
Valinejad Alley, Valiasr St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Office of Vice-chancellor for Research, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mesbah Kiaee
Position
Faculty member
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
1593748711
Phone
+98 21 8670 2503
Fax
Email
dr.mmesbah@gmail.com
Web page address
http://iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mesbah Kiaee
Position
Faculty member
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
1593748711
Phone
+98 21 8670 2503
Fax
Email
dr.mmesbah@gmail.com
Web page address
http://iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mesbah Kiaee
Position
Faculty member
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
1593748711
Phone
+98 21 8670 2503
Fax
Email
dr.mmesbah@gmail.com
Web page address
http://iums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)