Protocol summary

Summary
Objective: To investigate the effect of administration of vitamin C during kidney transplantation surgery on postoperative renal function. Study design: Triple blind randomized clinical trial. Inclusion criteria: patients who are undergoing kidney transplantation. Exclusion criteria: drug sensitivity; cardiomyopathy; chronic obstructive pulmonary disease (COPD) and respiratory diseases; intraoperative hypotension; inotrope requirement during the surgery. Intervention: The 64 kidney recipients were divided into two groups (A & B). The patients in group “A” received infusion of 100 mg / kg (total volume with normal saline 50 cc) within 6 hours, and patients in group “B” received infusion of normal saline(50 cc) within 6 hours. Venous blood sampling was done for all patients in 3 stages (at the beginning of the operation, 1 and 2 hours after declamping of renal artery) to check MDA (Malondealdehyde) and TAC (total antioxidant status) as markers of free oxygen radicals activity and body oxidant status. Also graft function was monitored by measurement of BUN, creatinine, GFR and need for hemodialysis on the first 5 days and also 1 month after transplantation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081319470N37
Registration date: 2016-09-04, 1395/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ascorbic Acid infusion during renal transplantation on post-operative renal function status in the Kidney Transplantation Patients
Public title
The effect of Ascorbic Acid infusion during kidney transplantation on post-operative renal function in the Kidney Transplantation Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are undergoing kidney transplantation. Exclusion criteria: drug sensitivity; cardiomyopathy; chronic obstructive pulmonary disease (COPD) and respiratory diseases; intraoperative hypotension; inotrope requirement during the surgery.
Age
To 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to randomization, by using the site www.randomization.com twenty-frequency (permutation) binary of A and B were made then draw the group receiving vitamin C (A or B) is determined. To assign patients to one of the two groups two patients who are supposed to use a donor kidneys become a pair. Of the individual pairs that his/her last name comes first in alphabetical view is selected as the upper part of the B-A block.if the alphabetical view of the initial word of the family name was similar then we will use the alphabetical order of the first name and if similar initial word of the father name and at least national code will be used. After obtaining consent patients without the knowledge that which of the syringe is vitamin C or saline divided into two groups of case and control. (Syringes with volume of 50 cc and same shape. And a person who is unaware of the study prepares Syringes with labeled A, B on which they put at the disposal of researchers.)

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, Shiaz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.SUMS.MED.1394.S87

Health conditions studied

1

Description of health condition studied
Kidney transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status

Primary outcomes

1

Description
to check the MDA (Malondialdehyde)
Timepoint
In 3 stages (at the beginning of the operation, 1 and 2 hours after declamping of renal artery)
Method of measurement
by spectrophotometry

2

Description
to check the TAC (total antioxidant status)
Timepoint
In 3 stages (at the beginning of the operation, 1 and 2 hours after declamping of renal artery)
Method of measurement
spectrophotometry

3

Description
graft function of kidney monitoring after transplantation
Timepoint
daily for 5 days in the ICU and one mounth after kidney transpalantation
Method of measurement
measurement of BUN, creatinine, GFR and need for hemodialysis

Secondary outcomes

empty

Intervention groups

1

Description
patients in group A received vitamin C 100 mg / kg (total volume with normal saline 50 cc) within 6 hours
Category
Treatment - Drugs

2

Description
Patients in the control group received a 50 cc normal saline within 6 hours.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Mohammad Bagher Khosravi
Street address
Namazi Hospital, Namazi squer
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiaz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor of Research,7th Floor of Central Building of Shiraz University of Medical Sciences, Zand streetl
City
Shiraz
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, Shiaz 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
Seeyed Javad Enjoo
Position
Anesthesiology Resident/Physician
Other areas of specialty/work
Street address
Anesthesiology Department,Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
enjoosj@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Mohamad bagher Khosravi
Position
Cardio,Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
khosravimb@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Anesthesiology and Critical Care Research Center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, Khalili street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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