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

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03391830
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 15, 2018
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Contrast Induced-Acute Kidney Injury [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 [30 days]

   measured in ml/min/1.73m2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center	Mansourah	Aldakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

• Study Chair: Yasser Othman, MD, Urology and nephrology center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 5, 2018
• Last Update Posted: Jan 12, 2021
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Ascorbic Acid; Atorvastatin

Study Results

No Results Posted as of Jan 12, 2021