Prospective, controlled, single-blind, bicentric, randomized study on the safety of HES 130/0.42 combined with a balanced electrolyte solution vs. 5% Albumin combined with an unbalanced electrolyte solution (NaCl 0.9%) in patients with compensated renal failure

B. Braun Melsungen AG0 个研究点开始时间: 2008年12月16日最近更新: 2013年4月1日

适应症

试验速览

暂无简介。

•- Male or female patients older than 50 years of age
•- Patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl
•- Patients scheduled for elective intervention
•- Patients with an estimated intraoperative volume need of at least 1 L colloids
•- Patients suffering from non-oliguric renal failure
•- Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations
•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

•- Patients of ASA-class > III
•- Patients with daily urine output < 1L
•- Patients on haemodialysis
•- Patients receiving HES during the last 48 hours before first infusion of the investigational products
•- Patients suffering from coagulation disorders (i.e. PTT > 60 sec)
•- Patients with a hemoglobin < 9 g/dl
•- Patients with known hypersensitivity to HES, albumin or any of the excipients
•- Patients suffering from contraindications of the investigational products (i.e. Hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic fuction, congestive heart failure)
•- Simultaneous participation in another clinical trial
•- Emergencies
•- Patients incapable to give informed consent (e. g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of conciousness)

发起方