HFR A-equilibrium on Cardiovascular Stability (AIMS)

Azienda Ospedaliera di Lecco

Status and phase: Completed; Phase 4

Conditions: Hypotension

Treatments: Device: Standard sodium dialysate; Device: Automated sodium profiling in endogenous hemodiafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01414842

HFR-BFBCK0611 (Other Identifier)

HFR-AE-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard

Active Comparator group

Description:

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

Treatment:

Device: Standard sodium dialysate

Automated profiled

Experimental group

Description:

Automate sodium profiling in endogenous hemodiafiltration

Treatment:

Device: Automated sodium profiling in endogenous hemodiafiltration