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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808795
• Other study ID #: 487
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2008
• Last updated: December 15, 2008
• Start date: April 2006
• Est. completion date: October 2006

Study information

• Verified date: December 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Kidney Diseases
• Radiocontrast-Induced Nephropathy
• Renal Insufficiency, Chronic

Intervention

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 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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Heart center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CIN, defined as increase in serum creatinine concentration>=0.5mg/dL(44.2micromol/L) or >=25% above baseline.		48 hours after exposure to contrast medium	No
Secondary	Change in serum creatinine		48 hours after exposure to contrast medium	No
Secondary	Change in serum urea nitrogen		48 hours after exposure to contrast medium	No
Secondary	Change in Glomerular filtration rate(GFR)		48 hours after exposure to contrast medium	No