Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine

Study Overview
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Brief Summary
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The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.

Official Title
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Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine

Conditions
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Renal Dialysis

Intervention / Treatment
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* Device: Convergence Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be up to 18-85 years Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges. Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia <25% in the last 3 Months Well-functioning AVF vascular access: access recirculation ≤10% No coagulation disorders and anticoagulant therapy Patients must be using a similar size dialyzer as Convergence dialyzer Signed Inform consent form. Exclusion Criteria: Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study. History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment. Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal. Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma). Temporary excluded will be patients with increased body temperature due to some infective disease, dehydration, diarrhea, hyperglycemia, Severe bleeding, or history or evidence of bleeding diathesis or coagulopathy with the risk of bleeding or have to put on dialysis without anticoagulant. Using temporary or permanent dialysis catheter Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator. Known pregnancy and lactating without pregnancy test Patient has known allergy or hypersensitivity reaction to dialyzer membrane or other disposable Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator Any other conditions at the discretion of investigator not suitable for patients to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interventional Group<br>Each patient will be treated for one session of dialysis after enrolled. Each of them will have only one treatment in the middle of the week (Wednesday or Thursday). The patients will be treated using 4008A dialysis machines in combination with a sidecar and the convergence dialyzer as investigational devices.Each patient will be treated according their regular treatment and laboratory analysis will be taken. The blood level of free hemoglobin ( fHb ) will be taken on 30 min by use of HemoCue device. ACT time will be measured on 15 min and for that 0.5 ml blood from venous line will be taken. | Device: Convergence Dialyzer<br>* The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Alarms | Incidence of alarms leading to end of treatment, cause identification | 1 study day | 
| Product defects | Product defects leading to end of treatment, cause identification | 1 study day | 
| Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect | Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect | 1 study day | 
| Incidence of recoverable alarms | Incidence of recoverable alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits | 1 study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate | The completion rate of a dialysis session according to prescription. The study is considered to be successful, if at least 8 patients reach the effective dialysis time. | 1 study day | 
| Average Blood Flow Rate | The average blood flow rate is measured during the dialysis treatment. Maintenance of preset blood flow rates throughout the dialysis in at least 8 out of 10 patients | 1 study day | 
| Arterial pressure | The arterial pressure is measured in mmHg. | 1 study day | 
| Venous pressure | The venous pressure is measured in mmHg. | 1 study day | 
| Impeller RPM | The rotation of the impeller pump is measured in rpm. | 1 study day | 
| Dialysis Dose as single pool Kt/V | The delivered dialysis dose as single-pool Kt/V. Achievement of a spKt/V > 1.4 in at least 8 out of 10 patients. | 1 study day | 
| Dialysis Dose as Urea Reduction Ratio (URR) | The delivered dialysis dose as URR. | 1 study day | 
| Ultrafiltration Volume | Total ultrafiltration volume (ml). Achievement of preset total ultrafiltration volume (ml) to reach dry weight target in at least 8 out of 10 patients. | 1 study day | 
| Body weight change | Patient body weight change (before treatment vs. after treatment). | 1 study day | 
| pH | The blood level of pH is measured pre/post HD. Achievement of results in laboratory acceptable ranges, | 1 study day | 
| Bicarbonate | The blood level of Bicarbonate is measured pre/post HD. Achievement of results in laboratory acceptable ranges. | 1 study day | 
| Potassium | The blood level of Potassium is measured pre/post HD. Achievement of results in laboratory acceptable ranges, | 1 study day | 
| Sodium | The blood level of Sodium is measured pre/post HD. Achievement of results in laboratory acceptable ranges. | 1 study day | 
| Chloride | The blood level of Chloride is measured pre/post HD. Achievement of results in laboratory acceptable ranges. | 1 study day | 
| Free hemoglobin | The blood level of free hemoglobin (fHb measured on 30 min) to be in acceptable ranges for hemolysis | 1 study day | 
| Anticoagulation | The total dose of anticoagulation consumption not to exceed patient treatment dose as I.U per kg | 1 study day | 
| Clotting Score | The clotting score of dialyzer(visual check, using common scale for dialyzer study) No visible thrombosed fibers A few visible thrombosed fibers Moderately visible thrombosed fibers Many visible thrombosed fibers Completely visible thrombosed fibers So the score goes from 1 (good) to 5 (bad). | 1 study day |