Chronic haemodialysis patients 18 years upwards. Patients should be in a stable condition during their chronic dialysis program (no ongoing infections or active extensive tumour with CRP above 30 mg/l). (men and women, not limited to a specific subdiagnose). Most women in the dialysis program are non fertile due to severe disturances of their hormone regulation. Level: LLT Classification code 10066622 Term:
Conditions
Interventions
Trade Name: Innohep (tinzaparin)
Product Name: Citrasate
Product Code: Medical Device product used as dialysate fluid
Pharmaceutical Form: Bath additive
Sponsors
Västerbottens läns landsting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Initially 20 patients will be included in the study (one center). Eventually, if data indicate a non expected outcome (this is a first pilot study in this field), approximately up to 40 patients on chronic haemodialysis will be included in the study (2 centers). Age above 18 years and no restriction to gender or race. consecutively asked and included). 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
Exclusion criteria
Exclusion criteria: If patient refuses and if patient is in a poor physical and medical condition (i.e. ongoing inflamamtion of more extensive degree such as CRP above 40 mg/l).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if lipoprotein lipase and its inhibitors together with its lipid degradation products (i.e., triglycerides) are differently altered using Citrasate for dialysis (in the dialysate fluid only as a Medical device product) than using standard dialysis with tinzaparin as anticoagulant. ;Secondary Objective: May long term use of citrate containing dialysate improve lipid degradation in haemodialysis patients?;Primary end point(s): This is a paired (case-control) study where the same patient is investigated using two different routine haemodialysis settings. Blood sampling during dialysis is performed once using each established dialysis technique. It will be prformed as a randomized cross-over study with each patient as their own controls. | — |
Countries
Sweden
Outcome results
None listed