HFR A-equilibrium on Cardiovascular Stability

NCT ID: NCT01414842

Last Updated: 2011-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-12-31

Brief Summary

Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

Detailed Description

Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in some large observational studies (Canaud et al, KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve patients outcomes. Moreover, it has been demonstrated in randomized controlled trials (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities and ageing of dialysis population require further devices able to improve treatment tolerance. Among these tools, the sodium profiling and biofeedback system seem to be promising to accomplish this task. But the correct intradialytic sodium balance is still far away today to be easily achieved. The use of an automated adaptive system dialysis to the sodium profiling has been investigated in a feasibility trial (Colì et al International Journal Artificial Organs, 2003). They also investigated the impact of such a device on treatment tolerance.

The aim of this randomized multinational multicenter controlled trial is to evaluate the impact of sodium profiling applied to a endogenous hemodiafiltration technique on the intradialytic cardiovascular stability in comparison to standard no profiled endogenous hemodiafiltration.

Conditions

Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard

Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration

Group Type: ACTIVE_COMPARATOR

Standard sodium dialysate

Intervention Type: DEVICE

Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration

Automated profiled

Automate sodium profiling in endogenous hemodiafiltration

Group Type: EXPERIMENTAL

Automated sodium profiling in endogenous hemodiafiltration

Intervention Type: DEVICE

Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.

Interventions

Automated sodium profiling in endogenous hemodiafiltration

Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.

Intervention Type: DEVICE

Standard sodium dialysate

Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration

Intervention Type: DEVICE

Other Intervention Names

HFR-Aequilibrium; Standard HFR

Eligibility Criteria

Inclusion Criteria

• Patients with more than 30% of dialysis complicated by hypotension
• age between 18 and 85 yers
• time on dialysis greater than 6 months
• residual creatinine clearance less than 2 ml/min/1.73 m2
• native fistula or central venous catheter with blood flow rate greater than 250 ml/min

Exclusion Criteria

• Life expectancy less than 1 year
• solid active neoplasm
• pregnancy
• major event in the previous 3 months (ictus, myocardial infarction, cachexia)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: collaborator

Centre Pasteur Vallery Radot

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliera di Lecco

OTHER

Sponsor Role: lead

Responsible Party

Francesco Locatelli

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Locatelli, Prof.

Role: STUDY_CHAIR

Azienda Ospedaliera di Lecco

Locations

Hospital Erasme

Brussels, , Belgium

Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat

Paris, , France

Civil Hospital Bretagne Atlantique

Vannes, , France

Clinic of Internal Medicine

Rostock, , Germany

Nephrology and Dialysis Unit Ospedali Riuniti

Ancona, , Italy

UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi

Bologna, , Italy

Civil Hospital

Cirié, , Italy

PO Lastaria

Foggia, , Italy

Hospital Maggiore della Carità

Novara, , Italy

Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Ospedale San Giovanni Bosco

Torino, , Italy

Hospital Val d'Hebron

Barcelona, , Spain

Countries

Belgium; France; Germany; Italy; Spain

References

Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

Reference Type: DERIVED

PMID: 39498822 (View on PubMed)

Other Identifiers

HFR-BFBCK0611

Identifier Type: OTHER

Identifier Source: secondary_id

HFR-AE-2006

Identifier Type: -

Identifier Source: org_study_id