HemoControl System Activated in Hemodiafiltration Treatments (SOCRATHE)
Renal Failure
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure
Eligibility Criteria
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.
Sites / Locations
- Policlinico Sant'Orsola Malpighi
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
HD and HDF
HDF and HD
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.
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) .