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

February 2, 2010 updated by: Thammasat University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumtani
      • Khlong Luang, Pathumtani, Thailand, 12121
        • Adis Tasanarong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
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.
Other Names:
  • jelly
Active Comparator: alpha tocopherol
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.
Other Names:
  • Bio-E-vitamin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Adis Tasanarong, MD, Faculty of Medicine, Thammasat University (Rangsit Campus)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-I-1-53/52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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