EUCTR2007-007132-25-DE进行中（未招募）不适用
A randomized, double blind, parallel, placebo controlled, exploratory study to assess the effect of EA-230 on renal function and on safety and tolerability in patients at increased risk of developing renal failure following major cardiac on-pump surgery.
EBI Anti Sepsis B.V.0 个研究点目标入组 150 人开始时间: 2009年2月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients of at least 18 years old
- •2.Patients who are scheduled to undergo major elective cardiac surgery
- •3.Patients who are willing to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients undergoing emergency surgery.
- •2.Severe congestive heart failure EF < 20 %.
- •3.Congenital heart disease other than corrected atrial septum defect or corrected ventricular septum defect.
- •4.Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
- •5.Previous organ transplantation.
- •6.Active or uncontrolled liver disease/hepatitis.
- •7.Any disease that (a) has required immunosuppressive drugs (including oral or parenteral corticosteroids) during the past 6 months, or that (b) is fairly likely to require administration of such drugs in the post-operative period. Examples of such diseases include COPD, asthma, chronic bronchitis, auto-immune diseases, and so on. However, inhaled or topical steroids are permitted.
- •8.Patients who are unable themselves to sign the informed consent form, whether because of strokes or cognitive defects (dementia or otherwise).
- •9.Confirmed HIV-positivity.
- •10.Active (acute) infectious disease and/or severe chronic infectious disease requiring antibiotic treatment.
- •11.Active renal disease with a primary cause, e.g. haemolytic uremic syndrome (HUS) or glomerulonephritis requiring immunosuppressive treatment.
- •12.Patients with kidney failure (calculated GFR [MDRD formula] < 30 mL/min or requiring any kind of dialysis).
- •13.If female, patients must either:
- •13a. be post-menopausal for at least 1 year, or
- •13b. have had a hysterectomy or tubal ligation;
- •If of childbearing potential, patients:
- •Must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin [hCG]) result after surgery.
- •And either:
- •13c. have maintained her normal menstrual pattern for the 3 months prior to study entry, and have taken hormonal contraceptives for at least 1 month prior to study entry, or
- •13d. will be using another medically acceptable method of contraception and agree to continue with the same method during the study.
- •14.Change of ACE and/or AT2 blockers or other medication that may affect renal function within four weeks prior to hospital admission.
- •15.History of chronic disease which may interfere with the assessment of safety and/or efficacy.
- •16.Suspected or confirmed intraoperative embolization, e.g. post-aortic cross-clamp cholesterol embolization.
研究者
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