NCT01582867

HemoControl System Activated in Hemodiafiltration Treatments

Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DEVICE	ARTIS hemodialysis system	Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B\_HC01

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-04-23
• Last updated: 2025-03-13

Locations

1 site across 1 country: Italy