Biocompatibility of a new acetic free dialysis fluid (Honeycit) compared to conventional dialysis fluid (Selectbag® One) in an open, randomised, prospective, controlled crossover study

Gambro Lundia AB (Sweden)0 个研究点目标入组 24 人开始时间: 2011年8月9日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Chronic renal failure
•2. Stable patients treated on Gambro Select® system (AK200S or AK200 Ultra S) 3 times/week for at least 4 weeks using SelectBag® One (Ca+1.5 mmol/l)
•3. Patients treated in haemodialysis (HD) or Haemodiafiltration (HDF) mode with a blood flow rate between 250-400 ml/min during 4-5.5 hours
•4. Patients treated with Gambro high flux filter; Polyflux 170H or Polyflux 210H
•5. Signed consent to participate in the study (informed consent)
•6. Patient aged 18 years or older, male or female
•7. Haemoglobin 10 to 13.5 g/dl (haematocrit 30% to 40%)
•8. Patients able to tolerate prescribed dialysis fluid with electrolyte concentrations as specified for the test device
•9. Technical survival during study period as judged by study investigator

•1. Known Human Immunodeficiency Virus (HIV), Hepatitis C or B Virus (HCV or HBV) infection (positive serology)
•2. Patients with ionized-calcium value < 1.1 mmol/l
•3. Patients unable to tolerate Citrate as judged by Investigator
•4. Patients using Citrate anticoagulation in usual HD treatment
•5. Pregnant / planning pregnancy and lactating women during study period
•6. Patients with acute inflammatory or infectious event which, as judge by Investigator, may affect the safety of the patient and/or the result of the study
•7. Patients with known haemodynamic instability that, as judged by the investigator, might cause clinical treatment problems
•8. Chronic single needle dialysis
•9. Participation in other studies during the study period that can affect the outcome of this study
•10. Patients not considered compliant in following the study protocol, as judged by Investigator

发起方

Gambro Lundia AB (Sweden)