NCT01414842

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

August 29, 2011

Status Verified

January 1, 2007

Enrollment Period

1.5 years

First QC Date

August 10, 2011

Last Update Submit

August 26, 2011

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • Number of dialysis complicated by at least one hypotension

    Hypotension definition: If predialysis systolic blood pressure greater than100 mmHg then a value during dialysis below 90 mmHg or any systolic blood pressure reduction greater than 25 mmHg in presence of symptoms or If predialysis systolic blood pressure less than 90 mmHg a reduction of at least 10% accompanied by symptoms

    six months

Secondary Outcomes (1)

  • Blood Pressure Intradialytic symptoms

    six months

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

Device: Standard sodium dialysate

Automated profiled

EXPERIMENTAL

Automate sodium profiling in endogenous hemodiafiltration

Device: Automated sodium profiling in endogenous hemodiafiltration

Interventions

Automated sodium profiling in endogenous hemodiafiltrationDEVICE

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.

Also known as: HFR-Aequilibrium
Automated profiled
Standard sodium dialysateDEVICE

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

Also known as: Standard HFR
Standard

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Erasme

Brussels, Belgium

Location

Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat

Paris, France

Location

Civil Hospital Bretagne Atlantique

Vannes, France

Location

Clinic of Internal Medicine

Rostock, Germany

Location

Nephrology and Dialysis Unit Ospedali Riuniti

Ancona, Italy

Location

UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi

Bologna, 40128, Italy

Location

Civil Hospital

Cirié, Italy

Location

PO Lastaria

Foggia, Italy

Location

Hospital Maggiore della Carità

Novara, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Ospedale San Giovanni Bosco

Torino, Italy

Location

Hospital Val d'Hebron

Barcelona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39498822DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Francesco Locatelli, Prof.

    Azienda Ospedaliera di Lecco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

April 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

August 29, 2011

Record last verified: 2007-01

Locations

BE(1)DE(1)FR(2)IT(7)ES(1)