Prevention of Contrast Induced Nephropathy by Erythropoietin
Recruitment status was: Recruiting
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.
Chronic Kidney Insufficiency
Drug: Epoetin beta
Drug: Saline 0.9%
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention|
- Incidence of Contrast Induced Nephropathy(CIN) [ Time Frame: 1-3 days after exposure to contrast media ] [ Designated as safety issue: No ]
- Enzymatic infarct size [ Time Frame: 6h and 12 h after exposure to contrast media ] [ Designated as safety issue: No ]Will be measured by Troponin and CK
- Hospital length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
- Renal replacement therapy [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ] [ Designated as safety issue: No ]
- Hospital mortality [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Drug: Epoetin beta
Other Name: Epoietin beta
|Placebo Comparator: Placebo||
Drug: Saline 0.9%
normal saline intravenously
Other Name: Hydration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364402
|Western Galilee Hospital|
|Principal Investigator:||Shaul Atar, MD||Western Galilee Hospital|