Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane

Study Overview
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Brief Summary
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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®).

Detailed Description
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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.

Official Title
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Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane

Conditions
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End Stage Renal Disease, Haemodialysis, Anticoagulation

Intervention / Treatment
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* Biological: unfractionated heparin
* Biological: 8% trisodium citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unfractionated heparin and 8% trisodium citrate<br>Unfractionated heparin and 8% trisodium citrate. | Biological: unfractionated heparin<br>* A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.<br>Biological: 8% trisodium citrate<br>* 8% trisodium citrate in the dose of 150 ml/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |