Statins for Prevention of Contrast Induced Nephropathy

Contrast Induced Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770796
• Other study ID #: Prato0702
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: October 15, 2015
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2015
• Source: Ospedale Misericordia e Dolce
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• Atorvastatin
80 mg die
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		within 5 days after contrast exposure	Yes
Secondary	Relative increase = 25% over baseline serum creatinine within 5 days after contrast agent administration		within 5 days after contrast agent administration	Yes
Secondary	Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration		1 month	Yes