HFR A-equilibrium on Cardiovascular Stability (AIMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Device: Standard sodium dialysate; Device: Automated sodium profiling in endogenous hemodiafiltration

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Hospital Erasme
• France
  • Paris, France
    • Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
  • Vannes, France
    • Civil Hospital Bretagne Atlantique
• Germany
  • Rostock, Germany
    • Clinic of Internal Medicine
• Italy
  • Ancona, Italy
    • Nephrology and Dialysis Unit Ospedali Riuniti
  • Bologna, Italy, 40128
    • UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
  • Ciriè, Italy
    • Civil Hospital
  • Foggia, Italy
    • PO Lastaria
  • Novara, Italy
    • Hospital Maggiore della Carità
  • San Giovanni Rotondo, Italy
    • Casa Sollievo della Sofferenza
  • Torino, Italy
    • Ospedale San Giovanni Bosco
• Spain
  • Barcellona, Spain
    • Hospital Val d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration	Device: Standard sodium dialysate; Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration; Other Names: Standard HFR
Experimental: Automated profiled; Automate sodium profiling in endogenous hemodiafiltration	Device: 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.; Other Names: HFR-Aequilibrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Intradialytic symptoms	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.	six months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Lecco
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Centre Pasteur Vallery Radot
• Investigators: Study Chair: Francesco Locatelli, Prof., Azienda Ospedaliera di Lecco

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 29, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: HFR-AE-2006; HFR-BFBCK0611 (Other Identifier: AOLecco)