HemoControl System Activated in Hemodiafiltration Treatments

NCT01582867 | Completed

• 1 other identifier: 1495
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Failure

Keywords

Hemodiafiltration; Hemodialysis; Sodium; Artis; renal failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• blood pressure

  Pre-dialytic within 18 weeks

• thirst perception

  during dialysis within 18 weeks

• weight gain

  between dialysis treatments within 18 weeks

Study Arms (2)

HD and HDF

EXPERIMENTAL

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

HDF and HD

EXPERIMENTAL

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

Interventions

ARTIS hemodialysis system DEVICE

Software versions: Control Product: 8.06.01KA. Study Product: 8.06.01B\_HC01

Also known as: Artis™ hemodialysis system, HEMOCONTROL™, GAMBRO

HD and HDF; HDF and HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Dasco S.p.A.: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Policlinico Sant'Orsola Malpighi

Bologna, (BO), 40138, Italy

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Antonio Santoro, Dr.

  POLICLINICO SANT'ORSOLA MALPIGHI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 23, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (1)