After getting permission from the ethics committee of Shiraz University of Medical Sciences and consultation with Statistics, 30 patients are identified by the group of brain death for organ donation in Nemazee Hospital, randomly divided into two groups based on computer randomize.
In Group 1, in ICU of brain death, 100 mg / kg ascorbic acid is infused over 20 minutes and Continues with 100 mg / kg for 6 hours before organ harvesting.
In group 2, the same volume of Normal-Saline is infused as a placebo to the patient. To check the status of renal ischemia, baseline values of NGAL is measured in all brain death patients in ICU prior to starting ascorbic acid and then repeat, before aortic clamping in donors and 4 hours after renal artery declamping in recipients.
After 24 hours, the amount of NGAL is measured in ward and then renal function is evaluated by the amount of BUN, Cr and urine out put. Also the total of diuretic drugs and frequency of dialysis will study for 5 days post operation period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070411853N2
Registration date:2013-09-08, 1392/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Mohammad Firoozifar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
firoozifar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Transplant Research Center,Shiraz University of Medical Sciences
Anesthesiology and Critical Care Research Center,Shiraz University of Medical Sciences
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early Outcome of Kidney Function After Transplantation when Use Vitamin C in Decease Donors.
Public title
Effect of Vitamin C in Kidney Function After Transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Brain Death Patients in range of 20-65 years old ; Patients with History of kidney problems under Dialysis in list of Transplantation; Patients with kidney problems with Age between
20-60 years
Exclusion criteria:Brain Death Patients with history of cardiac problems; Brain Death Patients with Cr>1.5 mg/dl; Brain Death Patients with Age>65 year; Patients with kidney problems with Age>65 years old
baseline values of NGAL is measured in all brain death patients in ICU prior to starting ascorbic acid and then repeat, before aortic clamping in donors and 4 and 24 hours after renal artery declamping in recipients.
Method of measurement
By Keith
2
Description
BUN
Timepoint
for 5 days post operation
Method of measurement
Lab
3
Description
Cr
Timepoint
for 5 days post operation
Method of measurement
Lab
4
Description
frequency of dialysis
Timepoint
for 5 days post operation
Method of measurement
measured in ward
5
Description
Total diuretic drugs
Timepoint
for 5 days post operation
Method of measurement
measured in ward
Secondary outcomes
empty
Intervention groups
1
Description
In this study, we investigated the protective effects of Ascorbic acid(1000 mg I.V. in intervention group) in renal cell damage due to ischemic-re perfusion injury, by measuring NGAL level in brain death patients in ICU, and follow function of these kidneys after transplant in operating room and in ward by repeated measuring of this bio marker
Category
Prevention
2
Description
In control group 10cc N/S ( Equivalent with 2 Ampul of Vitamin C) is injected within 6 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Firoozifar
Street address
Nemazi Hospital ,Zand Street, Shiraz, Fars, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hatam,Vice-Chancellery of Research and Technology
Street address
Zand street
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Khosravi
Position
Associate Professor of Department of Anerthesiology
Other areas of specialty/work
Street address
Nemazi Hospital
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
Email
khosravim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Firoozifar
Position
Fellowship in Anesthesia for Organ Transplantation
Other areas of specialty/work
Street address
Nemazi Hospital
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
Email
firoozifar@sums.ac.ir or m.firoozifar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Firoozifar
Position
Fellowship in Anesthesia for Organ Transplantation
Other areas of specialty/work
Street address
Nemazi Hospital
City
Shiraz
Postal code
Phone
+98 71 1233 7636
Fax
Email
firoozifar@sums.ac.ir or m.firoozifar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)