Prevention of Contrast Induced Nephropathy by Erythropoietin
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Erythropoietin
|
Drug: Epoetin beta
50,000U intravenously
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Saline 0.9%
normal saline intravenously
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Contrast Induced Nephropathy(CIN) [1-3 days after exposure to contrast media]
Secondary Outcome Measures
- Enzymatic infarct size [6h and 12 h after exposure to contrast media]
Will be measured by Troponin and CK
- 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]
Eligibility Criteria
Criteria
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.
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Patients with eGFR ≥ 60 ml/min/1.73m2.
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Chronic renal replacement therapy.
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Subject with active malignancy.
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Subject with any known history of seizure disorders.
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Subject with polycythemia.
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Uncontrolled hypertension.
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Known allergy or hypersensitivity to EPO.
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Use of EPO 1 week prior to randomization.
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Use of long acting EPO (CERA) during 1 month prior to randomization.
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Use of NAC or bicarbonate during 3 days prior to randomization.
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Contrast media exposure during the last 7 days before randomization.
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Pregnant or lactating women.
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Participation in other clinical trial.
-
Refusal or inability to give informed consent due to mental or physical state.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Western Galilee Hospital | Nahariya | Israel |
Sponsors and Collaborators
- Western Galilee Hospital-Nahariya
Investigators
- Principal Investigator: Shaul Atar, MD, Western Galilee Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EPO1