HFR A-equilibrium on Cardiovascular Stability (AIMS)

This study has been completed.
Sponsor:
Collaborators:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Centre Pasteur Vallery Radot
Information provided by (Responsible Party):
Francesco Locatelli, Azienda Ospedaliera di Lecco
ClinicalTrials.gov Identifier:
NCT01414842
First received: August 10, 2011
Last updated: August 26, 2011
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Hypotension
Device: Automated sodium profiling in endogenous hemodiafiltration
Device: Standard sodium dialysate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Lecco:

Primary Outcome Measures:
  • Number of dialysis complicated by at least one hypotension [ Time Frame: six months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Blood Pressure Intradialytic symptoms [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: HFR-Aequilibrium

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414842

Locations
Belgium
Hospital Erasme
Bruxelles, Belgium
France
Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
Paris, France
Civil Hospital Bretagne Atlantique
Vannes, France
Germany
Clinic of Internal Medicine
Rostock, Germany
Italy
Nephrology and Dialysis Unit Ospedali Riuniti
Ancona, Italy
UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
Bologna, Italy, 40128
Civil Hospital
Ciriè, 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
Spain
Hospital Val d'Hebron
Barcellona, Spain
Sponsors and Collaborators
Azienda Ospedaliera di Lecco
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Centre Pasteur Vallery Radot
Investigators
Study Chair: Francesco Locatelli, Prof. Azienda Ospedaliera di Lecco
  More Information

No publications provided

Responsible Party: Francesco Locatelli, Prof., Azienda Ospedaliera di Lecco
ClinicalTrials.gov Identifier: NCT01414842     History of Changes
Other Study ID Numbers: HFR-AE-2006, HFR-BFBCK0611
Study First Received: August 10, 2011
Last Updated: August 26, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014