Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure

Conditions
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Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Drug: Iloprost
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Iloprost | Drug: Iloprost<br>* Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups |  | 2-5 days after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast media, contrast nephropathy