CompletedNCT00808795Updated Dec 16, 2008

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

A Phase 3 interventional study of N-acetylcysteine and Placebo in Radiocontrast-Induced Nephropathy, Chronic Kidney Disease and Diabetes Mellitus, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-16.

Sponsored by Tehran University of Medical Sciences · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Radiocontrast-Induced Nephropathy
Chronic Kidney Disease
Diabetes Mellitus

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Keywords

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

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 90 participants (actual)

Study arms

Experimental
N-acetylcysteine
Drug: N-acetylcysteine
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugN-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).
DrugPlacebo
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).

What researchers measure

Primary outcomes

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 outcomes

Change in serum creatinine
Time frame: 48 hours after exposure to contrast medium
Change in serum urea nitrogen
Time frame: 48 hours after exposure to contrast medium
Change in Glomerular filtration rate(GFR)
Time frame: 48 hours after exposure to contrast medium

Study locations

1 site

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

References and documents

Publications

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. PubMed 19563648 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00808795
Lead sponsor: Tehran University of Medical Sciences
First posted: Dec 16, 2008
Start date: Apr 2006
Primary completion: Oct 2006
Completion: Oct 2006
Last update: Dec 16, 2008

Study contacts

Manouchehr - Amini, MD

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

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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