Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients

Overview

The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.

Full Title of Study: “Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2010

Detailed Description

Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.

Interventions

  • Drug: alpha tocopherol
    • The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
  • Drug: placebo
    • The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.

Arms, Groups and Cohorts

  • Active Comparator: alpha tocopherol
  • Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

  • The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.
    • Time Frame: 1 year

Secondary Measures

  • The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)

Exclusion Criteria

  • patients with acute kidney injury
  • end stage renal disease (requiring dialysis)
  • unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study)
  • allergy to any of the contrast agents
  • mechanical ventilation
  • suffered from congestive heart failure, cardiogenic shock or emergent angiography.
  • receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thammasat University
  • Provider of Information About this Clinical Study
    • Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus)
  • Overall Official(s)
    • Adis Tasanarong, MD, Principal Investigator, Faculty of Medicine, Thammasat University (Rangsit Campus)

Citations Reporting on Results

Tasanarong A, Piyayotai D, Thitiarchakul S. Protection of radiocontrast induced nephropathy by vitamin E (alpha tocopherol): a randomized controlled pilot study. J Med Assoc Thai. 2009 Oct;92(10):1273-81.

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