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: 2012年5月1日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Charité Universitaetsmedizin