Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease

Ospedale Misericordia e Dolce0 sites304 target enrollmentApril 2006

ConditionsContrast Induced Nephropathy

InterventionsPlacebo Atorvastatin

DrugsAtorvastatin Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Contrast Induced Nephropathy
Sponsor: Ospedale Misericordia e Dolce
Enrollment: 304
Primary Endpoint: Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

March 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ospedale Misericordia e Dolce

Responsible Party

Principal Investigator

Mauro Maioli

Ospedale Misericordia e Dolce

Eligibility Criteria

Inclusion Criteria

•patients with pre-angiographic estimated creatinine clearance \< 60 ml/min

Exclusion Criteria

•contrast medium administration within the previous 10 days
•end-stage renal failure requiring dialysis
•refusal to give informed consent
•previous therapy with statin

Arms & Interventions

Placebo

placebo

Intervention: Placebo

Atorvastatin

80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.

Intervention: Atorvastatin

Outcomes

Primary Outcomes

Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards

Time Frame: within 5 days after contrast exposure

Secondary Outcomes

Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration(within 5 days after contrast agent administration)
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration(1 month)