Chronic renal failure Urological and Genital Diseases Chronic renal failure
Conditions
Interventions
Patients will be randomised to receive dialysis with either
1. New acetic free dialysis fluid (Honeycit)
2. Conventional dialysis fluid (Selectbag® One)
Patients in each group will receive 6 weeks o
Sponsors
Gambro Lundia AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration (P) of Advanced Glycation End products (AGEs), analysed by fluorescence (em 430/ex 350), pre- and post- each 6 week treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety: 1.1. Adverse effects (AE) / Severe adverse effects (SAE) 1.2. Plasma (P)-Parathyroid hormone (PTH) 1.3. P-Ionized-calcium 1.4. P-Citrate 1.5. Blood gas (pH, PO2, PCO2, Base excess) 1.6. Blood (B)-Complete Blood Count (Haemoglobin [Hb], Haematocrit [Hct], White Blood Count [WBC], Red Blood Count [RBC] and Platelets) 1.7. P-Electrolytes (sodium [Na], potassium [K], total calcium [tot-Ca], chlorine [Cl], urea and albumin) 1.8. Blood pressure and heart rate 2. Inflammation: 2.1. P- C-reactive Protein (CRP) 2.2. B- Interleukin (IL)-6 2.3. B- IL-1ß 2.4. B- Tumour Necrosis Factor (TNF)-a 3. Coagulation: 3.1. B- Thrombin-Antithrombin (TAT) 3.2. B- Activated Partial Thromboplastin Time (APTT) 3.3. Visual rinse-back information and assessment 4. Additional exploratory parameters: 4.1. Biocompatibility: 4.1.1. Carboxymethyllysine (CML) 4.1.2. Pentosidine 4.1.3. Pentraxin-related protein (PTX3) 4.1.4. Glutathione (GSH/GSSG) 4.1.5. Malondialdehyde (MDA) 4.1.6. 8-Oxo-2'-deoxyguanosine (8-oxo-dG) 4.1.7. modified Advanced Oxidation Protein Product (mAOPP) (stress biomarker) 4.1.8 Total Aminothiols 4.2. Treatment parameters: 4.2.1. Treatment mode (HD/HDF) 4.2.2. Dialyser 4.2.3. Blood circuit and machine 4.2.4. Body weight before and after treatment 4.2.5. Treatment time 4.2.6. Blood flow rate 4.2.7. Dialysis flow rate 4.2.8. Ultra filtration rate and volume 4.2.9. Trans-Membrane Pressure (TMP) 4.2.10. Arterial and venous pressure 4.2.11. Accumulated blood volume and where applicable total infusion volume 4.2.12. Anticoagulation (type, dosage and administration) and potassium level. Diascan Kt/V All outcomes will be assessed pre- and post- each 6 week treatment phase. | — |
Countries
Sweden
Outcome results
None listed