Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease
Primary Purpose
Radiocontrast-Induced Nephropathy, Chronic Kidney Disease, Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Radiocontrast-Induced Nephropathy focused on measuring Acute kidney injury, contrast-induced nephropathy, Chronic kidney disease, Diabetes mellitus, N-acetylcysteine
Eligibility Criteria
Inclusion Criteria:
Patients who have all of the following criteria:
- Aged older than 18 years old
- A history of diabetes mellitus for at least one year
- chronic kidney disease, defined as serum creatinine concentration >=1.5mg/dL for men and >=1.4mg/dL for women.
Exclusion Criteria:
- Acute coronary syndrome requiring primary or rescue coronary intervention within less than 12h
- Cardiogenic shock
- Current peritoneal or hemo-dialysis
- A known allergy to NAC
Sites / Locations
- Tehran Heart center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-acetylcysteine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of CIN, defined as increase in serum creatinine concentration>=0.5mg/dL(44.2micromol/L) or >=25% above baseline.
Secondary Outcome Measures
Change in serum creatinine
Change in serum urea nitrogen
Change in Glomerular filtration rate(GFR)
Full Information
NCT ID
NCT00808795
First Posted
December 13, 2008
Last Updated
December 15, 2008
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00808795
Brief Title
Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease
Official Title
Efficacy of N-Acetylcysteine in Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization in Patients With Diabetes Mellitus and Chronic Kidney Disease: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired acute kidney injury, accounting for 10% of all cases.
The pathophysiology of CIN is unclear. Possible mechanisms involve
Renal tubular injury by oxygen free radicals
Reducing renal blood flow which leads to acute tubular necrosis. Since N-acetylcysteine is an antioxidant as well as a vasodilator, it may work in two distinct ways, by preventing reduction in renal blood flow or contrast-induced oxidative damage.
The purpose of this study is to evaluate the efficacy of N-acetylcysteine compared to placebo for the contrast-induced nephropathy prevention.
Detailed Description
Contrast-induced nephropathy (CIN) is the third most common cause of hospital acquired acute kidney injury, accounting for 10% of all cases. Nevertheless, use of radiocontrast media has been associated with increased in-hospital morbidity, mortality, and costs of medical care, long admission, especially in patients needing dialysis. With the increasing use of contrast media in diagnostic and interventional procedures, it has become one of the major challenges encountered during routine cardiovascular practice.
Patients at the greatest risk for CIN can be defined as those have preexisting impaired renal function and diabetes mellitus with incidence estimated to be as high as 50%. Preventive therapies primarily include limitation of contrast exposure, intravenous volume expansion with a saline solution, and use of a low- or iso-osmolality contrast media.
However, since these measures provide incomplete protection for CIN, interest has emerged in a number of adjunction short-term pharmacotherapy methods. Among them, N-acetylcysteine (NAC) has been of considerable interest. Up to now, several clinical studies and meta-analysis have been performed to assess the efficacy of NAC in prevention of CIN.
In spite of heterogeneity regarding efficacy of administration of NAC, several studies have advised the use of NAC, especially in high risk patients, with regard to its low cost, availability and few side effects. Since administration of NAC necessitates earlier and longer admission of patients, particularly in intravenous use, it can increase the health care costs. In addition, there are evidences that this intervention can even be harmful in patients with diabetes mellitus.
So, it seems that we need more evidences about the efficacy and cost-effectiveness of NAC in patients at high risk for development of CIN to make rational clinical decisions for individual patients as well as policy decisions for the health of the general public.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiocontrast-Induced Nephropathy, Chronic Kidney Disease, Diabetes Mellitus
Keywords
Acute kidney injury, contrast-induced nephropathy, Chronic kidney disease, Diabetes mellitus, N-acetylcysteine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of NAC is to be orally administered at the dose of 600mg twice a day, starting 24h before the procedure (two doses before and two doses after the procedure).
Primary Outcome Measure Information:
Title
Incidence of CIN, defined as increase in serum creatinine concentration>=0.5mg/dL(44.2micromol/L) or >=25% above baseline.
Time Frame
48 hours after exposure to contrast medium
Secondary Outcome Measure Information:
Title
Change in serum creatinine
Time Frame
48 hours after exposure to contrast medium
Title
Change in serum urea nitrogen
Time Frame
48 hours after exposure to contrast medium
Title
Change in Glomerular filtration rate(GFR)
Time Frame
48 hours after exposure to contrast medium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have all of the following criteria:
Aged older than 18 years old
A history of diabetes mellitus for at least one year
chronic kidney disease, defined as serum creatinine concentration >=1.5mg/dL for men and >=1.4mg/dL for women.
Exclusion Criteria:
Acute coronary syndrome requiring primary or rescue coronary intervention within less than 12h
Cardiogenic shock
Current peritoneal or hemo-dialysis
A known allergy to NAC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manouchehr - Amini, MD
Organizational Affiliation
Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tehran Heart center
City
Tehran
ZIP/Postal Code
1411713138
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
19563648
Citation
Amini M, Salarifar M, Amirbaigloo A, Masoudkabir F, Esfahani F. N-acetylcysteine does not prevent contrast-induced nephropathy after cardiac catheterization in patients with diabetes mellitus and chronic kidney disease: a randomized clinical trial. Trials. 2009 Jun 29;10:45. doi: 10.1186/1745-6215-10-45.
Results Reference
derived
Learn more about this trial
Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease
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