Study of the effects of N-acetylcysteine on oxidative stress status of patients on maintenance-hemodialysis undergoing cadaveric kidney transplantation
Objectives: The aim of the study is to assess the effect of N-acetylcysteine(NAC) on oxidative status of cadaveric kidney transplant recipients.
Design: A prospective, randomized, placebo-controlled clinical trial is conducted on deceased donor kidney recipients in two specialized medical center in Tehran, Iran.
Setting and conduct: Patients receive N-acetylcysteine or placebo in addition to immunosuppressant protocol including cyclosporine mycophenolate mofetil and corticosteroid.
Major Inclusion and Exclusion criteria: Patients on maintenance hemodialysis who undergoing cadaveric renal transplantation.
Intervention: Patients are randomly assigned to receive either NAC 600 mg or placebo one dose within 2 hours before transplantation followed by twice daily of the same dose up to the fifth day after transplantation.
Main outcome measures (variables): Glutathione peroxidase (GPX) activity in erythrocytes and serum malondialdehyde (MDA) levels are measured at baseline (pre-transplant) and five days after transplantation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081827346N4
Registration date:2016-09-18, 1395/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of N-acetylcysteine on oxidative stress status of patients on maintenance-hemodialysis undergoing cadaveric kidney transplantation
Public title
Study of N-acetylcysteine effects on oxidative stress markers and renal function in cadaveric kidney transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: "Patients on maintenance dialysis who are undergoing cadaveric renal transplantation"
Exclusion criteria: "preemptive kidney transplantation (transplantation prior to initiation of dialysis), multi-organ transplants, second transplantation, history of using NAC within the month prior to operation, and history of sensitivity to sulfa drugs"
Age
From 18 years old to 75 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The randomization is performed using the RAND function in Microsoft Excel.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Postal code
1985717443
Approval date
2014-06-15, 1393/03/25
Ethics committee reference number
153
Health conditions studied
1
Description of health condition studied
patients on maintenance-hemodialysis who are undergoing cadaveric kidney transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Glutathione peroxidase activity in erythrocytes and serum malondialdehyde levels
Timepoint
pre-transplantation and 5 days after transplantation
Method of measurement
Randox Laboratories commercial kits for Glutathione peroxidase and biochemical method for malondialdehyde
Secondary outcomes
1
Description
Serum creatinine
Timepoint
daily
Method of measurement
biochemical method
Intervention groups
1
Description
In intervention group 600 mg acetylcysteine is administered one dose before transplantation and then twice per day from day one to five after transplantation.
Category
Prevention
2
Description
In control group placebo is administered one dose before transplantation and then twice per day from day one to five after transplantation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Hospital
Full name of responsible person
Dr Mohsen Nafar
Street address
9th Boostan, Pasdaran St. Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Nima Naderi
Street address
Niayesh Highway, Valiasr Ave, Tehran
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, Shahid Beheshti 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
school of pharmacy
Full name of responsible person
Atieh Modarresi
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Fax
Email
atieh.modaresi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of pharmacy
Full name of responsible person
Dr Shadi Ziaie
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Fax
Email
Shadiziaie@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, school of pharmacy
Full name of responsible person
Atieh Modarresi
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Fax
Email
atieh.modaresi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)