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HemoControl System Activated in Hemodiafiltration Treatments (SOCRATHE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Gambro Dasco S.p.A.
ClinicalTrials.gov Identifier:
NCT01582867
First received: April 16, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Renal Failure
 Device: ARTIS hemodialysis system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Gambro Dasco S.p.A.:

Primary Outcome Measures:
  • Sodium mass balance [ Time Frame: during dialysis treatment within 18 weeks ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • blood pressure [ Time Frame: Pre-dialytic within 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: during dialysis within 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: between dialysis treatments within 18 weeks ] [ Designated as safety issue: No ]
    difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment


Estimated Enrollment: 6
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582867

Locations
Italy
Policlinico Sant'Orsola Malpighi
Bologna, (bo), Italy, 40138
Sponsors and Collaborators
Gambro Dasco S.p.A.
Gambro Dialysatoren GmbH
Investigators
Principal Investigator: Antonio Santoro, Dr. POLICLINICO SANT'ORSOLA MALPIGHI
  More Information

No publications provided

Responsible Party: Gambro Dasco S.p.A.
ClinicalTrials.gov Identifier: NCT01582867     History of Changes
Other Study ID Numbers: 1495
Study First Received: April 16, 2012
Last Updated: January 15, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Gambro Dasco S.p.A.:
Hemodiafiltration
Hemodialysis
Sodium
Artis
renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013