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| Name | Class |
|---|---|
| Fresenius Medical Care Deutschland GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convergence Dialyzer | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Babalj-Banskolieva, Dr. | Specialized Hospital for Nephrology and Dialysis Diamed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Special Hospital for Nephrology and Dialysis Diamed | Skopje | 1000 | North Macedonia |
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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)
So the score goes from 1 (good) to 5 (bad). | 1 study day |