Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00808795

Purpose

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
1. Renal tubular injury by oxygen free radicals
2. 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.

Condition	Intervention	Phase
Radiocontrast-Induced Nephropathy Chronic Kidney Disease Diabetes Mellitus	Drug: N-acetylcysteine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in serum creatinine [ Time Frame: 48 hours after exposure to contrast medium ] [ Designated as safety issue: No ]
Change in serum urea nitrogen [ Time Frame: 48 hours after exposure to contrast medium ] [ Designated as safety issue: No ]
Change in Glomerular filtration rate(GFR) [ Time Frame: 48 hours after exposure to contrast medium ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	April 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
N-acetylcysteine: Experimental	Drug: N-acetylcysteine 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).
Placebo: Placebo Comparator	Drug: Placebo 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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808795

Locations

Iran, Islamic Republic of
Tehran Heart center
Tehran, Iran, Islamic Republic of, 1411713138

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Director:

Manouchehr - Amini, MD

Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital

More Information

No publications provided

Responsible Party:	- ( Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital )
Study ID Numbers:	487
Study First Received:	December 13, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808795 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Acute kidney injury
contrast-induced nephropathy
Chronic kidney disease
Diabetes mellitus
N-acetylcysteine

Study placed in the following topic categories:

Renal Insufficiency
Antioxidants
Metabolic Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Endocrine System Diseases
Antiviral Agents
Urologic Diseases
Renal Insufficiency, Chronic

Expectorants
Acetylcysteine
Kidney Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
N-monoacetylcystine
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Renal Insufficiency
Antioxidants
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetes Mellitus
Kidney Failure, Chronic
Endocrine System Diseases
Protective Agents
Antiviral Agents

Pharmacologic Actions
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Expectorants
Free Radical Scavengers
Acetylcysteine
Kidney Diseases
Glucose Metabolism Disorders
N-monoacetylcystine
Antidotes
Kidney Failure

ClinicalTrials.gov processed this record on July 06, 2009