Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy

N/ACompletedNCT03391830

Mansoura University250 enrolled

Overview

To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

250

Conditions

Contrast-induced Nephropathy Statin Ascorbic Acid AKI

Interventions

Atorvastatin-Ascorbic acidDRUG

atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Planned computed tomography urogram (CTU) * Statin naive, or not on statin treatment for at least 14 day Exclusion Criteria: * History of liver disease or elevated serum transaminases * History of rhabdomyolysis or elevated creatinine kinase * History of iodinated CM use within 14 days before randomization * History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure. * History of hypersensitivity reaction to contrast media * Pregnancy or lactation * Acute renal failure * End-stage renal disease requiring dialysis * Cardiogenic shock or pulmonary edema * Multiple myeloma

Locations (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Outcomes

Primary Outcomes

Contrast Induced-Acute Kidney Injury

Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.

Time frame: 3 days

Secondary Outcomes

long-term Renal function by estimated GFR

measured in ml/min/1.73m2

Time frame: 30 days

Data from ClinicalTrials.gov

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