HFR A-equilibrium on Cardiovascular Stability

Hypotension Clinical Trial

— AIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414842
• Other study ID #: HFR-AE-2006
• Secondary ID: HFR-BFBCK0611
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: August 26, 2011
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2007
• Source: Azienda Ospedaliera di Lecco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension

Intervention

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

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Bruxelles
France	Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat	Paris
France	Civil Hospital Bretagne Atlantique	Vannes
Germany	Clinic of Internal Medicine	Rostock
Italy	Nephrology and Dialysis Unit Ospedali Riuniti	Ancona
Italy	UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi	Bologna
Italy	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
Spain	Hospital Val d'Hebron	Barcellona

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Lecco	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Centre Pasteur Vallery Radot

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No