Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
NCT ID: NCT01403506
Last Updated: 2011-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2011-04-30
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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N-Acetyl Cysteine
N-Acetyl Cysteine: receive N-Acetyl Cysteine in addition to standard treatment
N-acetyl Cysteine
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
standard treatment
This group is without N-Acetyl Cysteine : just receives standard treatment
No interventions assigned to this group
Interventions
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N-acetyl Cysteine
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Shaheed Beheshti Medical University
Principal Investigators
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Jamshid Salamzadeh, PhD
Role: STUDY_DIRECTOR
SBMU School of Pharmacy, Tehran, Iran
Locations
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Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Other Identifiers
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186
Identifier Type: -
Identifier Source: org_study_id
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