Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy (CHART study) - CHART

udwigs Maximilians University0 个研究点开始时间: 2011年7月26日最近更新: 2015年9月14日

适应症

试验速览

暂无简介。

•Patients male or female, aged 18 to 85 years
•Patient undergoing cystectomy with urinary diversion by an ileum conduit or neobladder
•Ability to follow study instructions and likely to attend and complete all required visits
•Written 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 105
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Unfavorable prognosis (e. g. palliative surgical care in cases of obstruction of the efferent urinary tract)
•Evidence for metastatic disease
•Coagulopathy or platelet dysfunction
•Preoperative creatinine clearance <30ml/min
•Preoperative chemotherapy with nephrotoxic drugs (e. g. Cisplatin)
•Application of more than 1000ml colloid solution within the last 24 hours before surgical intervention
•Physical or acute medical condition, psychiatric condition or laboratory abnormality which at the investigator’s discretion may put the patient at risk, may confound the trial results, or may interfere with the patient’s participation in this clinical trial
•History of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
•History of uncontrolled chronic disease or a concurrent clinically significant illness, medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures
•Known or persistent abuse of medication, drugs or alcohol
•Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.

发起方

udwigs Maximilians University