NCT01364402

Prevention of Contrast Induced Nephropathy by Erythropoietin

Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI. The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.

Detailed description

Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI). The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.

Conditions

• Diabetes
• Chronic Kidney Insufficiency

Interventions

Type	Name	Description
DRUG	Epoetin beta	50,000U intravenously
DRUG	Saline 0.9%	normal saline intravenously

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2011-06-02
• Last updated: 2012-10-10

Locations

1 site across 1 country: Israel