Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Study Overview
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Brief Summary
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The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Detailed Description
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The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease (CKD). The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Official Title
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Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization

Conditions
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Kidney Diseases, Diabetes Mellitus, Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency

Intervention / Treatment
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* Drug: Alprostadil ﹠control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient that underwent coronary angiography T2DM CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2 Alprostadil naive, or not on Alprostadil treatment for at least 14 days Withdrawal metformin or aminophylline for 48h before angiography Exclusion Criteria: serum Cr. More than 3 mg/dl electrolyte and acid-base imbalance pulmonary edema allergy to Alprostadil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alprostadil, Control<br>Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography | Drug: Alprostadil ﹠control<br>* control:Normal salin 1cc/kg/hr before and after angiography<br>* Other names: Drug: normal salin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure | 72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome | The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. | 30 d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Induced Nephropathy