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

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

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

Study Overview

• Status: Completed
• Conditions: AKI; Contrast-induced Nephropathy; Statin; Ascorbic Acid
• Intervention / Treatment: Drug: Placebo; Drug: Atorvastatin-Ascorbic acid

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aldakahlia
    • Mansourah, Aldakahlia, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term Renal function by estimated GFR	measured in ml/min/1.73m2	30 days

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Yasser Othman, MD, Urology and nephrology center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: December 30, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protective Agents; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Vitamins; Antioxidants; Atorvastatin; Ascorbic Acid
• Other Study ID Numbers: CN PREVENTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No