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

Not Applicable

Completed

• Conditions: AKI; Contrast-induced Nephropathy; Statin; Ascorbic Acid
• Interventions: Drug: Placebo; Drug: Atorvastatin-Ascorbic acid

• Registration Number: NCT03391830
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-30
• Study First Submitted QC: 2017-12-30
• Study First Posted: 2018-01-05
• Study Start: 2018-01-15
• Status Verified: 2018-05
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Atorvastatin-Ascorbic acid	Atorvastatin-Ascorbic acid	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

Primary Outcome Measures

Name	Time	Method
Contrast Induced-Acute Kidney Injury	3 days	Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.

Secondary Outcome Measures

Name	Time	Method
long-term Renal function by estimated GFR	30 days	measured in ml/min/1.73m2

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansourah, Aldakahlia, Egypt