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Completed

NCT Number: NCT03391830

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

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

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Key information

Conditions

Contrast-induced Nephropathy AKI Ascorbic Acid Statin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin-Ascorbic acid

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Contrast Induced-Acute Kidney Injury

    Time frame: 3 days

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

Secondary outcomes

  1. long-term Renal function by estimated GFR

    Time frame: 30 days

    measured in ml/min/1.73m2

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2018
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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