HemoControl System Activated in Hemodiafiltration Treatments

Renal Failure Clinical Trial

— SOCRATHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582867
• Other study ID #: 1495
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: April 19, 2017
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Device:
• ARTIS hemodialysis system
Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola Malpighi	Bologna	(bo)

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dasco S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sodium mass balance	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.	during dialysis treatment within 18 weeks
Secondary	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
Secondary	thirst perception	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
Secondary	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