HemoControl System Activated in Hemodiafiltration Treatments (SOCRATHE)

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

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

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Device: ARTIS hemodialysis system

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • (bo)
    • Bologna, (bo), Italy, 40138
      • Policlinico Sant'Orsola Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD and HDF; 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.	Device: ARTIS hemodialysis system; Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01; Other Names: Artis™ hemodialysis system; HEMOCONTROL™; GAMBRO
Experimental: HDF and HD; 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) .	Device: ARTIS hemodialysis system; Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01; Other Names: Artis™ hemodialysis system; HEMOCONTROL™; GAMBRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Gambro Dasco S.p.A.
• Investigators: Principal Investigator: Antonio Santoro, Dr., Policlinico Sant'Orsola Malpighi

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 23, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: renal failure; Hemodialysis; Sodium; Hemodiafiltration; Artis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 1495 (Other Identifier: CSL Behring)