This necessitates the studies and interventions to improve outcome of renal transplantation surgery. Delayed Graft Function (DGF) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. DGF is a consequence of ischemic and reperfusion injuries (IRI), and oxygen free radicals have a main role in pathophysiology of DGF. In meta-analysis studies, it has been demonstrated that DGF has a correlation with long and short time graft survival. Despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. Major causes of this problem are the lack of appropriate markers for early diagnosis of DGF and on the other hand lack of appropriate and effective interventions to controll DGF. Studies have shown that N-Acetyl Cysteine (NAC) can induce GSH synthesis, scavenger of free radicals, and infusion of NAC had similar effects as glutathione. This is a randomized clinical trial (RCT) on patients who have received kidney transplantation from living donors. Sixty transplanted patients will be randomized into 2 groups. The first group of patients will be treated with NAC 600mg 6 hr before transplantation and two doses of NAC 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. For all patients entered the study, urinary concentrations of IL18 and NGAL will be measured in designated times. Risk factors of DGF will be compared in two groups and effectiveness of NAC in reducing DGF will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067490N1
Registration date:2011-10-11, 1390/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-11, 1390/07/19
Registrant information
Name
Zahra Sahraee
Name of organization / entity
School of pharmacy, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences; School of pharmacy, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-04-01, 1390/01/12
Expected recruitment end date
2012-11-01, 1391/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of N-acetyl cysteine on the renal graft function biomarkers (IL18, NGAL)
Public title
Study of the effect of N-acetyl cysteine on the renal graft function biomarkers (IL18, NGAL)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: patient receiving transplantation from living donors.
Exclusion Criteria:
having a neoplastic disease; brain tumor; having inflammatory diseases in their active phase (SLE); an acute infection, meningitis, sepsis; Sickle Cell Disease; Pregnancy; Cardio-renal syndrome; endogenous Cushing's syndrome; chronic use of cimetidine; a history of acute pancreatitis in recent months; Multiple Sclerosis; cardiac bypass in a recent month; cirrhosis due to Hepatitis C; having Alzheimer's disease; having a untreated major depressive illness or schizophrenia; Stroke in recent months; Hyperoxaluria sensitivity to sulfonamides.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrial.gov
Secondary trial Id
NCT01403506
Registration date
2011-07-26, 1390/05/04
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti Unive
Street address
9 th Bostan, Pasdaran st.
City
Tehran
Postal code
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
13
Health conditions studied
1
Description of health condition studied
Delayed graft function after kidney transplantation
ICD-10 code
N29.8*
ICD-10 code description
Other disorders of kidney and ureter in other diseases classified elsewhere
Primary outcomes
1
Description
IL 18, NGAL
Timepoint
4 and 24 hr after transplantation
Method of measurement
Elisa kit
Secondary outcomes
1
Description
dialysis requirement
Timepoint
60 days after transplantation
Method of measurement
observation
Intervention groups
1
Description
First group: 600 mg of N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation
Category
Treatment - Drugs
2
Description
Second group: only standard antirejection treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad hospital
Full name of responsible person
Dr.Mohsen Nafar
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Cen
Full name of responsible person
Dr.Mohsen Nafar
Street address
9th Bostan, Pasdaran st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Cen
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
School of pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Jamshid Salamzadeh
Street address
Niyayesh cross road, Valiasr st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of pharmacy, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Zahra Sahraee
Position
resident of clinical pharmacy
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21888773704
Fax
Email
z_sahraee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Jamshid Salamzadeh
Position
associated professor
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21888773704
Fax
Email
j.salamzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)