Clinical trial NCT01582867: HemoControl System Activated in Hemodiafiltration Treatments
Official title: Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: Hemodiafiltration
Hemodialysis
Sodium
Artis
renal failure
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dasco S.p.A.
name: Baxter Healthcare Corporation
First posted: 2012-04-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sodium mass balance
timeFrame: during dialysis treatment within 18 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: Pre-dialytic within 18 weeks
measure: thirst perception
timeFrame: during dialysis within 18 weeks
measure: weight gain
timeFrame: between dialysis treatments within 18 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
state: (bo)
Study officials:
affiliation: POLICLINICO SANT'ORSOLA MALPIGHI
name: Antonio Santoro, Dr.
role: PRINCIPAL_INVESTIGATOR
References: