The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

Not Applicable

Completed

• Conditions: Contrast-induced Acute Kidney Injury; Cardiovascular Diseases
• Interventions: Drug: Atorvastatin

• Registration Number: NCT04666389
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-10
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Written informed consent
• Indications for computer tomography with intravenous contrast media administration
• Cardiovascular diseases (arterial hypertension, arrhythmia etc)

Exclusion Criteria

• Pregnancy
• Statin therapy before inclusion in the study
• Acute coronary syndromes
• Contraindications for statins administration
• Patients with chronic kidney disease stages 4-5
• Contraindications for computer tomography with contrast media administration
• Nephrotoxic drugs use (NSAIDS, vancomycin etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Atorvastatin	No statins being used for prevention
Low-dose statin therapy	Atorvastatin	Atorvastatin 40 mg
High-dose statin therapy	Atorvastatin	Atorvastatin 80 mg

Primary Outcome Measures

Name	Time	Method
Contrast-induced acute kidney injury	48-72 hours after contrast media administration	Contrast induced acute kidney injury is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media.

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation