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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Nahariya、イスラエル
- 募集
- Western Galilee Hospital
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コンタクト：
- Shaul Atar, MD
- メール：shaul.atar@naharia.health.gov.il
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コンタクト：
- Batya Kristal, MD
- メール：batya.kristal@naharia.health.gov.il
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主任研究者：
- Shaul Atar, MD
-
主任研究者：
- Batya Kristal, MD
-
副調査官：
- Lilach Shema-Didi, RN, MPH
-
副調査官：
- Irith Weissman, MD
-
副調査官：
- Ronit Geron, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
|
normal saline intravenously
他の名前：
|
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実験的：Erythropoietin
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50,000U intravenously
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of Contrast Induced Nephropathy(CIN)
時間枠：1-3 days after exposure to contrast media
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1-3 days after exposure to contrast media
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Enzymatic infarct size
時間枠：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
時間枠：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
時間枠：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
|
|
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Hospital mortality
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Shaul Atar, MD、Western Galilee Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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