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

Thammasat University

Status and phase

Unknown

Phase 3

Conditions

Contrast Induced Nephropathy

Treatments

Drug: alpha tocopherol

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01061320

MTU-I-1-53/52

Details and patient eligibility

About

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 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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