Contrast Induced Nephropathy
Conditions
Keywords
Alpha-Tocopherol (Vitamin E), Contrast induced nephropathy, Chronic kidney disease, Coronary procedures
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.
Interventions
DRUGalpha 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.
DRUGplacebo
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.
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. | 1 year |
Countries
Thailand
Outcome results
None listed