Anticoagulation, End Stage Renal Disease, Haemodialysis
Conditions
Brief summary
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
Detailed description
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
Interventions
BIOLOGICALunfractionated heparin
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
BIOLOGICAL8% trisodium citrate
8% trisodium citrate in the dose of 150 ml/h.
Sponsors
Marija Malgaj Vrečko
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The research will be performed as a prospective clinical trial. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient on chronic hemodialysis * age 18 years old or more * being able to give an informed consent to participate in the survey
Exclusion criteria
* on therapeutic anticoagulation * citrate or heparin contraindicated * citrate or heparin intolerance * acute renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of beta-2 microglobulin | At the end of each hemodialysis procedure. | Overall and instantaneous clearance of beta-2 microglobulin. |
| Clearance of phosphate | At the end of each hemodialysis procedure. | Overall and instantaneous clearance of phosphate. |
| Serum concentration of C3a, C5a, myeloperoxidase and PF-4 | At the start, after 15 minutes and at the end of each hemodialysis procedure. | Blood for the laboratory measurements will be taken from the arterial line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| White blood cell count | At the start, after 15 minutes and at the end of each hemodialysis procedure. | Blood for the laboratory measurements will be taken from the arterial line. |
| Clearance of urea | At the end of each hemodialysis procedure. | Overall and instantaneous clearance of urea. |
| Blood platelet count | At the start, after 15 minutes and at the end of each hemodialysis procedure. | Blood for the laboratory measurements will be taken from the arterial line. |
| Clearance of creatinine | At the end of each hemodialysis procedure. | Overall and instantaneous clearance of creatinine. |
| Clearance of p-cresol | At the end of each hemodialysis procedure. | Overall and instantaneous clearance of p-cresol. |
Countries
Slovenia
Outcome results
None listed