EUCTR2007-002223-32-DE进行中（未招募）不适用
A multicentre, double-blind, randomised placebo-controlled trial of sodium bicarbonate to prevent acute kidney injury in patients undergoing cardiopulmonary bypass surgery. - Natriumbikarbonat-Studie
Charité Universitaetsmedizin0 个研究点目标入组 402 人开始时间: 2008年2月7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.
研究者
相似试验
进行中（未招募）
2 期
A multicentre, randomised, double-blind placebo-controlled, phase II study to evaluate the safety, tolerability and dose of dried intestinal microbiota medicinal product EBX-102 in liver cirrhosis subjects (IMPuLCE)iver cirrhosis and hepatic encephalopathyDigestive SystemISRCTN11352030Caidya60
招募中
不适用
A double-blind randomised multi-centre, placebo-controlled trial of combined angiotensin converting enzyme-inhibitor and beta-blocker therapy in preventing the development of cardiomyopathy in genetically characterised males with Duchenne Muscular Dystrophy without echo-detectable left ventricular dysfunctioNervous System DiseasesDiseases of myoneural junction and muscleDuchenne muscular dystrophyISRCTN50395346ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)140
进行中（未招募）
1 期
A double-blind randomised multi-centre, placebo-controlled trial of combined ACE-inhibitor and beta-blocker therapy in preventing the development of cardiomyopathy in genetically characterised males with DMD without echo-detectable left ventricular dysfunction - DMD-Heart ProtectioMedDRA version: 9.1 Level: LLT Classification code 10013801 Term: Duchenne muscular dystrophyDuchenne muscular dystrophyEUCTR2007-005932-10-GBewcastle upon Tyne Hospitals NHS Foundation Trust85
进行中（未招募）
不适用
ot applicableSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2011-002901-31-HUMundipharma Research GmbH & Co. KG210
进行中（未招募）
1 期
A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated paiSubjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2011-002901-31-GBMundipharma Research GmbH & Co. KG202