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Completed

NCT Number: NCT01414842

HFR A-equilibrium on Cardiovascular Stability

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Erasme, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Automated sodium profiling in endogenous hemodiafiltration

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.

Other names: HFR-Aequilibrium

Standard sodium dialysate

Device

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

Other names: Standard HFR

Primary outcomes

  1. Number of dialysis complicated by at least one hypotension

    Time frame: six months

    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

Secondary outcomes

  1. Blood Pressure Intradialytic symptoms

    Time frame: six months

    Systolic, diastolic blood pressures (SBP, DBP) and heart rate (HR) measured at the beginning of each treatment and every 30 minutes till the end of dialysis; intradialytic symptoms (nausea, vomiting, hypotension, headache, cramps) and related clinical interventions.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Lecco

Other

Collaborators

  • Centre Pasteur Vallery Radot
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Registry information

Official study title

Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients

Acronym: AIMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 11, 2011
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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