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

NCT ID: NCT01061320

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Contrast Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

alpha tocopherol

Group Type: ACTIVE_COMPARATOR

alpha tocopherol

Intervention Type: DRUG

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.

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Bio-E-vitamin; jelly

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Faculty of Medicine, Thammasat University (Rangsit Campus)

Principal Investigators

Adis Tasanarong, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Thammasat University (Rangsit Campus)

Locations

Adis Tasanarong

Khlong Luang, Pathumtani, Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 19845233 (View on PubMed)

Related Links

http://www.nephrothai.org/

The Nephrology Society of Thailand

Other Identifiers

MTU-I-1-53/52

Identifier Type: -

Identifier Source: org_study_id