NCT01722513

Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Alprostadil ﹠control	control:Normal salin 1cc/kg/hr before and after angiography

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2012-11-07
• Last updated: 2012-11-07

Locations

1 site across 1 country: China