Prevention of Contrast Induced Nephropathy by Erythropoietin
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|ClinicalTrials.gov Identifier: NCT01364402|
Recruitment Status : Unknown
Verified September 2011 by Western Galilee Hospital-Nahariya.
Recruitment status was: Recruiting
First Posted : June 2, 2011
Last Update Posted : October 10, 2012
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|
|Diabetes Chronic Kidney Insufficiency||Drug: Epoetin beta Drug: Saline 0.9%||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||December 2013|
Drug: Epoetin beta
Other Name: Epoietin beta
|Placebo Comparator: Placebo||
Drug: Saline 0.9%
normal saline intravenously
Other Name: Hydration
- Incidence of Contrast Induced Nephropathy(CIN) [ Time Frame: 1-3 days after exposure to contrast media ]
- Enzymatic infarct size [ Time Frame: 6h and 12 h after exposure to contrast media ]Will be measured by Troponin and CK
- Hospital length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
- Renal replacement therapy [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ]
- Hospital mortality [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364402
|Contact: Lilach Shema-Didi, RN, MPHfirstname.lastname@example.org|
|Contact: Lilach Shema-Didi, RN, MPH||Lilach.Shema-Didi@naharia.health.gov.il|
|Western Galilee Hospital||Recruiting|
|Contact: Shaul Atar, MD email@example.com|
|Contact: Batya Kristal, MD firstname.lastname@example.org|
|Principal Investigator: Shaul Atar, MD|
|Principal Investigator: Batya Kristal, MD|
|Sub-Investigator: Lilach Shema-Didi, RN, MPH|
|Sub-Investigator: Irith Weissman, MD|
|Sub-Investigator: Ronit Geron, MD|
|Principal Investigator:||Shaul Atar, MD||Western Galilee Hospital|