Renal Failure
Conditions
Keywords
Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure
Brief summary
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Detailed description
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.
Interventions
DEVICEARTIS hemodialysis system
Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B\_HC01
Sponsors
Gambro Dasco S.p.A.
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject must meet ALL of the following inclusion criteria in order to participate in this study: * ESRD in chronic dialysis treatments for at least 3 months * Age ≥ 18 years * Body weight ≥ 40 kg * Blood flow rate ≥ 250 ml/min with a recirculation of the vascular access \< 5% * Use of not fractioned heparin in continuous infusion as anticoagulant * Stable anticoagulation dosage over the last 6 treatments * Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments * Informed consent for participating to the study * Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.
Exclusion criteria
* A subject shall NOT participate in the study if he/she meets ANY of the following criteria: * HIV positivity * Active Hepatitis A, B or C * Pregnancy * Participating in other clinical investigations during the course of this study * Failed to release consent * Known coagulation disorders (clotting problems) * Known bleeding risk * Clinical or laboratory diagnosis of acute infection * Recent (last 4 weeks) surgical intervention * Therapy prescribed is only HD, HF or isolated UF mode * Active phase cancer, * Active phase immune disease. * Serious hemostasis disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sodium mass balance | during dialysis treatment within 18 weeks | * to determine whether the same HemoControl prescription is usable in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments and, if not, * to assess the existence of a proper HemoControl prescription in On-Line Hemodiafiltration (HDF) treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | Pre-dialytic within 18 weeks | difference between the pre-treatment systolic and diastolic blood pressures in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) with respect to the control treatments |
| thirst perception | during dialysis within 18 weeks | 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 |
| weight gain | between dialysis treatments within 18 weeks | difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment |
Countries
Italy
Outcome results
None listed