Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
Overview
- Phase
- Phase 3
- Intervention
- Epoetin beta
- Conditions
- Diabetes
- Sponsor
- Western Galilee Hospital-Nahariya
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Incidence of Contrast Induced Nephropathy(CIN)
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Over 18 years of age.
- •Diabetic patients.
- •eGFR \< 60 ml/min/1.73m
- •Scheduled for primary or elective PCI.
Exclusion Criteria
- •Non diabetic patients.
- •Patients with eGFR ≥ 60 ml/min/1.73m
- •Chronic renal replacement therapy.
- •Subject with active malignancy.
- •Subject with any known history of seizure disorders.
- •Subject with polycythemia.
- •Uncontrolled hypertension.
- •Known allergy or hypersensitivity to EPO.
- •Use of EPO 1 week prior to randomization.
- •Use of long acting EPO (CERA) during 1 month prior to randomization.
Arms & Interventions
Erythropoietin
Intervention: Epoetin beta
Placebo
Intervention: Saline 0.9%
Outcomes
Primary Outcomes
Incidence of Contrast Induced Nephropathy(CIN)
Time Frame: 1-3 days after exposure to contrast media
Secondary Outcomes
- Hospital mortality(participants will be followed after PCI procedure till discharge, an expected average of 1-2 days)
- Enzymatic infarct size(6h and 12 h after exposure to contrast media)
- Renal replacement therapy(participants will be followed after PCI procedure till discharge, an expected average of 1-2 days)
- Hospital length of stay(participants will be followed for the duration of hospital stay, an expected average of 3 days)