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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Nahariya, 이스라엘
- 모병
- Western Galilee Hospital
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연락하다:
- Shaul Atar, MD
- 이메일: shaul.atar@naharia.health.gov.il
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연락하다:
- Batya Kristal, MD
- 이메일: batya.kristal@naharia.health.gov.il
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수석 연구원:
- Shaul Atar, MD
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수석 연구원:
- Batya Kristal, MD
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부수사관:
- Lilach Shema-Didi, RN, MPH
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부수사관:
- Irith Weissman, MD
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부수사관:
- Ronit Geron, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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normal saline intravenously
다른 이름들:
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실험적: Erythropoietin
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50,000U intravenously
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of Contrast Induced Nephropathy(CIN)
기간: 1-3 days after exposure to contrast media
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1-3 days after exposure to contrast media
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Enzymatic infarct size
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Shaul Atar, MD, Western Galilee Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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