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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00808795
First received: December 13, 2008
Last updated: December 15, 2008
Last verified: December 2008
  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 3

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


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
Experimental: N-acetylcysteine 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 Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences, Nephrology Department of Dr. Shariati Hospital, -
ClinicalTrials.gov Identifier: NCT00808795     History of Changes
Other Study ID Numbers: 487
Study First Received: December 13, 2008
Last Updated: December 15, 2008
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

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 20, 2014