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

Mansoura University

Status: Completed

Conditions: Ascorbic Acid; AKI; Statin; Contrast-induced Nephropathy

Treatments: Drug: Atorvastatin-Ascorbic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03391830

CN PREVENTION

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Atorvastatin-Ascorbic acid

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin-Ascorbic acid

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo