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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
-
Nahariya, Israel
- Rekrutierung
- Western Galilee Hospital
-
Kontakt:
- Shaul Atar, MD
- E-Mail: shaul.atar@naharia.health.gov.il
-
Kontakt:
- Batya Kristal, MD
- E-Mail: batya.kristal@naharia.health.gov.il
-
Hauptermittler:
- Shaul Atar, MD
-
Hauptermittler:
- Batya Kristal, MD
-
Unterermittler:
- Lilach Shema-Didi, RN, MPH
-
Unterermittler:
- Irith Weissman, MD
-
Unterermittler:
- Ronit Geron, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Placebo
|
normal saline intravenously
Andere Namen:
|
|
Experimental: Erythropoietin
|
50,000U intravenously
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Incidence of Contrast Induced Nephropathy(CIN)
Zeitfenster: 1-3 days after exposure to contrast media
|
1-3 days after exposure to contrast media
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Enzymatic infarct size
Zeitfenster: 6h and 12 h after exposure to contrast media
|
Will be measured by Troponin and CK
|
6h and 12 h after exposure to contrast media
|
|
Hospital length of stay
Zeitfenster: participants will be followed for the duration of hospital stay, an expected average of 3 days
|
participants will be followed for the duration of hospital stay, an expected average of 3 days
|
|
|
Renal replacement therapy
Zeitfenster: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
|
participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
|
|
|
Hospital mortality
Zeitfenster: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
|
participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Shaul Atar, MD, Western Galilee Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EPO1
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .