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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391830
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

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

Condition or disease Intervention/treatment Phase
Contrast-induced Nephropathy Statin Ascorbic Acid AKI Drug: Atorvastatin-Ascorbic acid Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: 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
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. long-term Renal function by estimated GFR [ Time Frame: 30 days ]
    measured in ml/min/1.73m2


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391830


Locations
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Egypt
Urology and Nephrology Center
Mansourah, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Yasser Othman, MD Urology and nephrology center
More Information
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Responsible Party: Abdelwahab Hashem, Clinical Uro-oncology Fellow - Urology and Nephrology Center - Mansoura, Mansoura University
ClinicalTrials.gov Identifier: NCT03391830    
Other Study ID Numbers: CN PREVENTION
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Ascorbic Acid
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients