HemoControl System Activated in Hemodiafiltration Treatments (SOCRATHE)

This study has been completed.
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: July 8, 2013
Last verified: July 2013

April 16, 2012
July 8, 2013
May 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01582867 on ClinicalTrials.gov Archive Site
  • 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
  • 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 HC+HDF 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 HC+HDF 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 HC+HDF treatments with respect to the control treatment
Not Provided
Not Provided
 
HemoControl System Activated in Hemodiafiltration Treatments
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Failure
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: 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.
    Intervention: Device: ARTIS hemodialysis system
  • 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) .
    Intervention: Device: ARTIS hemodialysis system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01582867
1495
No
Gambro Dasco S.p.A.
Gambro Dasco S.p.A.
Gambro Dialysatoren GmbH
Principal Investigator: Antonio Santoro, Dr. POLICLINICO SANT'ORSOLA MALPIGHI
Gambro Dasco S.p.A.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP