Effect of hypertonic saline 5% and sodium bicarbonate 8.4% on early graft function and the urinary levels of IL-18 and Neutrophil Gelatinase-associated Lipocalin (NGAL) as biomarkers of acute kidney injury in patients receiving kidney transplants from deceased donors
The study designed to evaluate the effect of the intra-operative administration of hypertonic saline 5 % and sodium bicarbonate 8.4% on early graft function and urinary levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin-10 (IL-10).
The patients age of 18 to 65 years old who receive kidney transplant from decease donor were included in this study and any patient with sever acidosis and/or electrolytes abnormality were excluded.
A total of 60 patients were randomly assigned to three groups: hypertonic saline, sodium bicarbonate and control; In the control group, patients receive 60 ml/kg of normal saline as intraoperative fluid therapy. In hypertonic saline, 4 ml/kg hypertonic saline 5% administered about 30 minutes before the declamping of kidney artery. In Sodium bicarbonate group, intraoperative pH is controlled tightly based on Base deficit values by administration of sodium bicarbonate 8.4% and base deficit maintain above -5 mmol/L.
The primary outcomes are early graft function and urinary levels of IL- 18 and NGAL. To asses early graft function, serum creatinin, BUN and urine volume is measured in predefine time ponits.
Urology Research Center,Tehran University of Medical Sciences,Tehran,Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
pourmand@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
TUMS
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hypertonic saline 5% and sodium bicarbonate 8.4% on early graft function and the urinary levels of IL-18 and Neutrophil Gelatinase-associated Lipocalin (NGAL) as biomarkers of acute kidney injury in patients receiving kidney transplants from deceased donors
Public title
comparison the effect of hypertonic saline and sodium bicarbonate on early graft function in kidney transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients candidate for a kidney transplant from deceased donor;the ages of 18 to 65;left ventricular ejection fraction >30%.
Exclusion criteria:sever acidosis (pH<7.2 and/or HCO3<15 and/or BD<-15);serum K>5.5 or serum K<3.5;serum Na>150 or serum Na<135;blood product transfusion
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
TUMS-Ettics commitee in research
Street address
keshavars st
City
tehran
Postal code
Approval date
2013-12-28, 1392/10/07
Ethics committee reference number
92-02-47-23360-102797
Health conditions studied
1
Description of health condition studied
kidney transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
serum creatinin
Timepoint
befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant
Method of measurement
jaffe method
2
Description
BUN
Timepoint
befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant
Method of measurement
colorimetric method
3
Description
urin volume
Timepoint
recovery, 6, 12, 24, 48 hr after operation
Method of measurement
obsevation
4
Description
NGAL
Timepoint
0,24,48 hr after operation
Method of measurement
ELISA
5
Description
IL-10
Timepoint
0,24,48 hr after operation
Method of measurement
ELISA
Secondary outcomes
1
Description
base deficit
Timepoint
before and every 30 minutes during operation
Method of measurement
ABG analyzer
2
Description
serum K
Timepoint
before and during operation
Method of measurement
flame photometry
3
Description
HCO3
Timepoint
before and every 30 minutes during operation
Method of measurement
ABG analyzer
4
Description
pCO2
Timepoint
before and every 30 minutes during operation
Method of measurement
ABG analyzer
5
Description
serum Cl
Timepoint
before and during operation
Method of measurement
flame photometry
6
Description
serum Na
Timepoint
before and during operation
Method of measurement
flame photometry
7
Description
pO2
Timepoint
before and every 30 minutes during operation during operation
Method of measurement
mmHg-ABG analyzer
8
Description
pH
Timepoint
before and every 30 minutes during operation
Method of measurement
ABG analyzer
Intervention groups
1
Description
hypertonic saline group:
4ml/kg hypertonic saline 5% is administered before declamping during kidney transplant procedure.
Category
Treatment - Drugs
2
Description
control group;
60 ml/kg normal saline solution administered during kidney transplant procedure to maintain CVP between 8 and 15 cm H2O
Category
Treatment - Drugs
3
Description
sodium bicarbonate group:
during kidney transplant procedure pH is controlled tightly based on BD values by administration of sodium bicarbonate 8.4% and BE maintained above -5 m mol/L.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Javad Motaharinia-clinical pharmacy resident
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Research Council of Tehran University of Medical Sciences
Street address
Research Council of Tehran University of Medical Sciences-Qods building-boulvar keshavarz
City
Qods building-boulvar keshavarz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Farhad Etezadi
Position
anesthesiologist,assistant professor
Other areas of specialty/work
Street address
Sina Hospital-Imam khomeini street
City
Tehran
Postal code
Phone
+98 910 212 1843
Fax
Email
etezadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Univesity of Medical Sciences
Full name of responsible person
Farhad Etezadi
Position
anesthesiologist- assistant professor
Other areas of specialty/work
Street address
Sina Hospital- Imam khomeini street
City
Tehran
Postal code
Phone
+98 910 212 1843
Fax
Email
etezadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center,Tehran University of Medical Sciences,Tehran,Iran.
Full name of responsible person
Gholamreza Pourmand
Position
Director of Urology Research Center, Tehran University of Medical Sciences-Dean of Sina University H
Other areas of specialty/work
Street address
Urology Research Center,Sina Hospital,Imam khomeini street
City
Tehran
Postal code
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
gh_pourmand@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)