EUCTR2007-002223-32-IE进行中（未招募）不适用
A multicentre, double-blind, randomised controlled trial of sodium bicarbonate to prevent acute kidney injury in patients undergoing cardiopulmonary bypass surgery. - Sodium Bicarbonate Study
Charité Universitaetsmedizin0 个研究点目标入组 402 人开始时间: 2009年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
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
- •Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned and:
- •Written informed consent of patient
- •No present pregnancy
- •Highly effective contraception in women with childbearing potential (Pearl index < 1)
- •No participation in another clinical study (AMG) at the time of this study
- •and having at least one ore more of the following risk factors for post-operative acute kidney injury
- •Age = 70 years
- •Preoperative plasma creatinine >120 µmol/L
- •Heart failure (NYHA class III / IV)
- •Insulin dependent diabetes mellitus
- •Valve surgery (with or without coronary artery bypass graft surgery)
- •Redo cardiac surgery
- •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
- •Cardiac surgical patients will not be considered eligible if:
- •The use of cardiopulmonary bypass is not planned (off-pump cardiac surgery) or
- •An emergency operation is indicated (within 24 hours after first description of cardiac symptoms)
- •The above mentioned risk definition for post-operative acute kidney injury is not fulfilled or
- •Women of childbearing age without highly effective contraception (PEARL-Index < 1%) or breastfeeding is present or
- •Contraindications against the study medication are present such as alkalosis or hypokalemia or hypernatremia or
- •Absent willingness to allow storage or circulation of coded data collected for study reason or
- •Patient is accomodated in an institution of mental disorders on judicial or magisterial behalf or
- •Patients participate in another clinical study (AMG) or
- •Pre-operative end stage renal disease (serum creatinine >300 µmol/L) is present or
- •Known blood-borne infectious disease is present or
- •Chronic moderate to high dose corticosteroid therapy (>10 mg/d prednisone or equivalent) is present or
- •Age is below 18 years,
- •Legal responsibility
- •Persons who are detained officially or legally to an official institute.
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