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NCT03391830 Clinical Trial

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

Contrast-induced Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03391830
Other study ID # CN PREVENTION
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date January 1, 2020

Study information
Verified date May 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
Placebo

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansourah Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 long-term Renal function by estimated GFR measured in ml/min/1.73m2 30 days
See also
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Recruiting NCT02088502 - Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy Phase 2/Phase 3
Completed NCT03329443 - The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography Phase 2
Recruiting NCT04864847 - Clinical Validation of the RENISCHEM L-FABP POC Assay
Completed NCT03627130 - The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy Phase 2
Active, not recruiting NCT03736018 - Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients N/A
Withdrawn NCT04603261 - Time to Excretion of Contrast, a Maastricht Prospective Observational Study
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Active, not recruiting NCT04606056 - Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans
Terminated NCT02440646 - Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging
Completed NCT00175227 - Prevention of Contrast-Induced Nephropathy N/A
Completed NCT04014153 - CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
Withdrawn NCT04597892 - Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast
Completed NCT03305874 - Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
Not yet recruiting NCT01871792 - Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction Phase 4
Not yet recruiting NCT06429345 - Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients. Phase 4
Recruiting NCT05271448 - Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography N/A
Withdrawn NCT03806725 - Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography
Completed NCT04163250 - Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography