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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®).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unfractionated heparin and 8% trisodium citrate | Experimental | Unfractionated heparin and 8% trisodium citrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unfractionated heparin | Biological | A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of beta-2 microglobulin | Overall and instantaneous clearance of beta-2 microglobulin. | At the end of each hemodialysis procedure. |
| Clearance of phosphate | Overall and instantaneous clearance of phosphate. | At the end of each hemodialysis procedure. |
| Serum concentration of C3a, C5a, myeloperoxidase and PF-4 | Blood for the laboratory measurements will be taken from the arterial line. | At the start, after 15 minutes and at the end of each hemodialysis procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of urea | Overall and instantaneous clearance of urea. | At the end of each hemodialysis procedure. |
| Clearance of creatinine | Overall and instantaneous clearance of creatinine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marija Malgaj Vrečko, MD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36303108 | Derived | Vrecko MM, Pajek J, Buturovic-Ponikvar J. Use of regional citrate anticoagulation with medium cut-off membrane: pilot report. BMC Nephrol. 2022 Oct 27;23(1):346. doi: 10.1186/s12882-022-02960-y. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| C514290 | trisodium citrate |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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.
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| 8% trisodium citrate | Biological | 8% trisodium citrate in the dose of 150 ml/h. |
|
| At the end of each hemodialysis procedure. |
| Clearance of p-cresol | Overall and instantaneous clearance of p-cresol. | At the end of each hemodialysis procedure. |
| White blood cell count | Blood for the laboratory measurements will be taken from the arterial line. | At the start, after 15 minutes and at the end of each hemodialysis procedure. |
| Blood platelet count | Blood for the laboratory measurements will be taken from the arterial line. | At the start, after 15 minutes and at the end of each hemodialysis procedure. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |