Prevention of Contrast Induced Nephropathy by Erythropoietin
Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Nahariya, Israel
- Rekruttering
- Western Galilee Hospital
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Ta kontakt med:
- Shaul Atar, MD
- E-post: shaul.atar@naharia.health.gov.il
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Ta kontakt med:
- Batya Kristal, MD
- E-post: batya.kristal@naharia.health.gov.il
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Hovedetterforsker:
- Shaul Atar, MD
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Hovedetterforsker:
- Batya Kristal, MD
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Underetterforsker:
- Lilach Shema-Didi, RN, MPH
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Underetterforsker:
- Irith Weissman, MD
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Underetterforsker:
- Ronit Geron, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
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normal saline intravenously
Andre navn:
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Eksperimentell: Erythropoietin
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50,000U intravenously
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of Contrast Induced Nephropathy(CIN)
Tidsramme: 1-3 days after exposure to contrast media
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1-3 days after exposure to contrast media
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Enzymatic infarct size
Tidsramme: 6h and 12 h after exposure to contrast media
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Will be measured by Troponin and CK
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6h and 12 h after exposure to contrast media
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Hospital length of stay
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 3 days
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participants will be followed for the duration of hospital stay, an expected average of 3 days
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Renal replacement therapy
Tidsramme: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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Hospital mortality
Tidsramme: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Shaul Atar, MD, Western Galilee Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EPO1
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