Contrast Induced Nephropathy
Conditions
Keywords
Contrast induced nephropathy
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.
Interventions
DRUGAtorvastatin
80 mg die
DRUGPlacebo
Sponsors
Ospedale Misericordia e Dolce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed