Statins for Prevention of Contrast Induced Nephropathy
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast induced nephropathy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Atorvastatin
Arm Description
placebo
80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
Full Information
NCT ID
NCT00770796
First Posted
October 9, 2008
Last Updated
October 15, 2015
Sponsor
Ospedale Misericordia e Dolce
1. Study Identification
Unique Protocol Identification Number
NCT00770796
Brief Title
Statins for Prevention of Contrast Induced Nephropathy
Official Title
Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
Contrast induced nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
80 mg die
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
Time Frame
within 5 days after contrast agent administration
Title
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Organizational Affiliation
Ospedale Misericordia e Dolce, Prato
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Statins for Prevention of Contrast Induced Nephropathy
We'll reach out to this number within 24 hrs