Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy
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|ClinicalTrials.gov Identifier: NCT01722513|
Recruitment Status : Unknown
Verified November 2012 by Ya-Wei Xu, Shanghai 10th People's Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : November 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases Diabetes Mellitus Acute Kidney Injury Kidney Failure, Chronic Renal Insufficiency||Drug: Alprostadil ﹠control||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||February 2014|
Experimental: Alprostadil, Control
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
control:Normal salin 1cc/kg/hr before and after angiography
- Primary Outcome [ Time Frame: 72 h ]An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
- Secondary Outcome [ Time Frame: 30 d ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722513
|Department of Cardiology, Shanghai Tenth People's Hospital|
|Shanghai, Shanghai, China, 200072|
|Principal Investigator:||Ya-Wei Xu, MD, FACC||Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine|