Prevention of Contrast Induced Nephropathy by Erythropoietin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Chronic Kidney Insufficiency

Intervention / Treatment
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* Drug: Epoetin beta
* Drug: Saline 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age. Diabetic patients. eGFR < 60 ml/min/1.73m2. Scheduled for primary or elective PCI. Exclusion Criteria: Non diabetic patients. Patients with eGFR ≥ 60 ml/min/1.73m2. 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. Use of NAC or bicarbonate during 3 days prior to randomization. Contrast media exposure during the last 7 days before randomization. Pregnant or lactating women. Participation in other clinical trial. Refusal or inability to give informed consent due to mental or physical state.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br> | Drug: Epoetin beta<br>* 50,000U intravenously<br>* Other names: Epoietin beta;|
| Placebo Comparator: Placebo<br> | Drug: Saline 0.9%<br>* normal saline intravenously<br>* Other names: Hydration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Contrast Induced Nephropathy(CIN) |  | 1-3 days after exposure to contrast media | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enzymatic infarct size | Will be measured by Troponin and CK | 6h and 12 h after exposure to contrast media | 
| Hospital length of stay |  | participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Renal replacement therapy |  | participants will be followed after PCI procedure till discharge, an expected average of 1-2 days | 
| Hospital mortality |  | participants will be followed after PCI procedure till discharge, an expected average of 1-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scheduled for PCI