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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
142
50,000U intravenously
normal saline intravenously
Western Galilee Hospital
Nahariya, Israel
RECRUITINGIncidence of Contrast Induced Nephropathy(CIN)
Time frame: 1-3 days after exposure to contrast media
Enzymatic infarct size
Will be measured by Troponin and CK
Time frame: 6h and 12 h after exposure to contrast media
Hospital length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Renal replacement therapy
Time frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Hospital mortality
Time frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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