Angioplasty, Transluminal, Percutaneous Coronary, Coronary Angiography, Renal Insufficiency, Chronic
Conditions
Keywords
contrast media, contrast nephropathy
Brief summary
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.
Interventions
DRUGIloprost
Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end
DRUGPlacebo
Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
Sponsors
Onassis Cardiac Surgery Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was \<60 ml/min on their most recent sample drawn within 1 month of the planned procedure
Exclusion criteria
* Circulatory shock for any reason, systolic blood pressure \<95 mm Hg * Known acute renal failure * End-stage renal disease requiring dialysis * Intravascular administration of a contrast medium within the previous 10 days * Anticipated re-administration of contrast medium within the following 6 days * Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure * Primary intervention for acute infarction with ST elevation * A procedure performed within 2 h of acute hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl | 2-5 days after the procedure |
| or CMN is defined as a relative rise of at least 25% from baseline on the follow-up | blood sample drawn at 2-5 days after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups | 2-5 days after the procedure |
Countries
Greece
Outcome results
None listed