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

Primary Purpose

Contrast-induced Nephropathy, Statin, Ascorbic Acid

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Atorvastatin-Ascorbic acid

Placebo

About this trial

This is an interventional prevention trial for Contrast-induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin-Ascorbic acid

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Contrast Induced-Acute Kidney Injury

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

Secondary Outcome Measures

long-term Renal function by estimated GFR

measured in ml/min/1.73m2

Full Information

NCT ID

NCT03391830

First Posted

December 30, 2017

Last Updated

January 8, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03391830

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 15, 2018 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast-induced Nephropathy, Statin, Ascorbic Acid, AKI

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin-Ascorbic acid

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Atorvastatin-Ascorbic acid

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Contrast Induced-Acute Kidney Injury

Description

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

Time Frame

3 days

Secondary Outcome Measure Information:

Title

long-term Renal function by estimated GFR

Description

measured in ml/min/1.73m2

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasser Othman, MD

Organizational Affiliation

Urology and nephrology center

Official's Role

Study Chair

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansourah

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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