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HemoControl System Activated in Hemodiafiltration Treatments (SOCRATHE)

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ARTIS hemodialysis system
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Policlinico Sant'Orsola Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HD and HDF

HDF and HD

Arm Description

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.

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) .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
weight gain
difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment

Full Information

First Posted
April 16, 2012
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dasco S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01582867
Brief Title
HemoControl System Activated in Hemodiafiltration Treatments
Acronym
SOCRATHE
Official Title
Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dasco S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD and HDF
Arm Type
Experimental
Arm Description
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.
Arm Title
HDF and HD
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
ARTIS hemodialysis system
Other Intervention Name(s)
Artis™ hemodialysis system, HEMOCONTROL™, GAMBRO
Intervention Description
Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01
Primary Outcome Measure Information:
Title
Sodium mass balance
Description
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.
Time Frame
during dialysis treatment within 18 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
difference between the pre-treatment systolic and diastolic blood pressures in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) with respect to the control treatments
Time Frame
Pre-dialytic within 18 weeks
Title
thirst perception
Description
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
Time Frame
during dialysis within 18 weeks
Title
weight gain
Description
difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment
Time Frame
between dialysis treatments within 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Santoro, Dr.
Organizational Affiliation
POLICLINICO SANT'ORSOLA MALPIGHI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
State/Province
(bo)
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

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HemoControl System Activated in Hemodiafiltration Treatments

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