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

NCT ID: NCT03391830

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-01-01

Brief Summary

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

Detailed Description

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Conditions

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Contrast-induced Nephropathy Statin Ascorbic Acid AKI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Atorvastatin-Ascorbic acid

Intervention Type 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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Abdelwahab Hashem

Clinical Uro-oncology Fellow - Urology and Nephrology Center - Mansoura

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser Othman, MD

Role: STUDY_CHAIR

Urology and nephrology center

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CN PREVENTION

Identifier Type: -

Identifier Source: org_study_id

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