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| Name | Class |
|---|---|
| Gambro Dasco S.p.A. | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.
The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD and HDF | Experimental | During one part of the study (study phase A) patients will undergo hemodialysis (HD) treatments with Hemoscan over 2 weeks (Run-In period), followed by 12 HD sessions with HemoControl during the following 4 to 6 weeks. Separated by a one week wash out period, the same patients will be switched to On-Line Hemodiafiltration (HDF) treatments (study phase B), for a Run-In period of 2 weeks with Hemoscan, followed by 12 On-Line HDF sessions with HemoControl over the last 4 to 6 weeks of the study period. |
|
| HDF and HD | Experimental | patients will be treated vice versa, starting with On-Line Hemodiafiltration (HDF) followed by hemodialysis (HD) with the same respective Run-In periods and a washout period as patients in Arm hemodialysis (HD) and Hemodiafiltration (HDF) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTIS hemodialysis system | Device | Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sodium mass balance |
| during dialysis treatment within 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | difference between the pre-treatment systolic and diastolic blood pressures in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) with respect to the control treatments | Pre-dialytic within 18 weeks |
| thirst perception |
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Inclusion Criteria:
A subject must meet ALL of the following inclusion criteria in order to participate in this study:
Exclusion Criteria:
A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Santoro, Dr. | POLICLINICO SANT'ORSOLA MALPIGHI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola Malpighi | Bologna | (BO) | 40138 | Italy |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Average difference between the thirst score reported by the patient during On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the score reported during the control treatments
| during dialysis within 18 weeks |
| weight gain | difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment | between dialysis treatments within 18 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |