This study is designed to determing the effect of tight blood sugar control in nondiabetic patient after kiney transplantation on graft function.This is a single blind study.Our study population will include patient with 18-70 years old.non diabetic,without prior transplantation that undergoing deceased donor renal transplantation or living donor transplantation . Patients,afer transplantation, were randomly allocated in two groups. In interventional group,Blood sugar(BS) is checked with glucometer after kidney transplantation in recovery room and every 2 hours.Infusion of regular insulin is started when BS is more than 140 mg,dl and continue for 48 hour..After 48 hours ,BS checks every 6 hours.If BS is more than 150 mg/dl subcutaneus insulin is given.
In control group,,BS checks every 6 hours.If BS is more than 150 mg/dl subcutaneus insulin is given.Then the prevalence of kidney rejection,Infections(urinary tract ,pneumonia,site of surgery infection)and mortality is compared in two groups in one mounth after transplantation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123011938N1
Registration date:2013-01-25, 1391/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-25, 1391/11/06
Registrant information
Name
Jila Rahmanian
Name of organization / entity
Ahvaz Joundi Shapoor University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 79 1333 0341
Email address
rahmanian.j@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapour University of Medical Science.
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of tight and accebtable glycemic control on the rate of
Acute rejection in nondiabetic patient after renal transplant
Public title
The effect of insulin infusion for tight glucose control on acute kidney rejection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :The End stage renal disease patient
exclusion criteria:Diabetic patient;Patients lesser than 18years of age;Patients more than 70 years of age
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AhvazJoundi Shapoor University of Medical Science
Street address
AhvazJoundi Shapoor University of Medical Science,Golestan
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
eth650
Health conditions studied
1
Description of health condition studied
kidney transplant rejection
ICD-10 code
T86.1
ICD-10 code description
Kidney transplant failure and rejection
Primary outcomes
1
Description
Acute kidney rejection
Timepoint
First mounth after transplant
Method of measurement
Creatine measurment
Secondary outcomes
1
Description
Dialysis
Timepoint
First week after transplantation
Method of measurement
Creatinin measurment
2
Description
Hypoglysemia
Timepoint
While insulin infusion
Method of measurement
Checking blood suger
3
Description
Infection
Timepoint
First mounth after transplantation
Method of measurement
Chest X ray, Urine analysis,Stool exam,
Intervention groups
1
Description
Blood sugar(BS) is checked every 2 hours after kidney transplantation.Infusion of regular insulin is started when BS is more than 140 mg,dl and continue for 48 hours.If BS 141-149 mg/dl insulin infusion 1.5 Unit per hour,BS 150- 179 mg/dl 2U insulin,BS 180- 209 mg/dl 3U insulin,BS 210- 239 mg/dl 4U insulin,BS 240- 269 mg/dl 5U insulin,BS 270-299 mg/dl 6U insulin,BS 300- 329 mg/dl7U insulin,BS 330- 359 mg/dl 8U insulin,BS >360 mg/dl 12 U insulin.After 48 hours ,BS checks every 6 hours.If BS is more than 150 mg/dl subcutaneus insulin is given.2 U insulin per 50 mg glucose over 150 mg.
Category
Treatment - Drugs
2
Description
Blood sugar(BS) is checked every 6 hours after kidney transplantation. .If BS is more than 150 mg/dl subcutaneus insulin is given.2 U insulin per 50 mg glucose over 150 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Transplant Department, Golestan Hospital, Ahvaz
Full name of responsible person
Jila Rahmanian,MD
Street address
Golestan Hospital, Golestan
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of JondiShapourAhvaz University of Medical Sciences
Full name of responsible person
Jila Rahmanian,MD
Street address
Ahvaz Joundi Shapoor University of Medical Science,Golestan
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of JondiShapourAhvaz 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
Ahvaz Jondi Shapor University of Medical Science
Full name of responsible person
Jila Rahmanian,MD
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Ahvaz Jondi Shapor University of Medical Science,Golestan
City
Ahvaz
Postal code
Phone
+98 79 1333 0341
Fax
Email
rahmanian.j@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Joundi Shapoor University of Medical Science
Full name of responsible person
Seyed Peyman Payami,MD
Position
Endocrinologost
Other areas of specialty/work
Street address
Ahvaz Joundi Shapoor University of Medical Science,Golestan
City
Ahvaz
Postal code
Phone
+98 61 1336 1984
Fax
Email
peyman_payami1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Joundi Shapoor University of Medical Science
Full name of responsible person
Jila Rahmanian,MD
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Ahvaz Joundi Shapoor University of Medical Science,Golestan
City
Ahvaz
Postal code
Phone
+98 61 1336 1984
Fax
Email
rahmanian.j@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)