HFR A-equilibrium on Cardiovascular Stability

Phase 4

Completed

• Conditions: Hypotension
• Interventions: Device: Standard sodium dialysate; Device: Automated sodium profiling in endogenous hemodiafiltration

• Registration Number: NCT01414842
• Lead Sponsor: Azienda Ospedaliera di Lecco

Brief 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.

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 Timeline

• Status Verified: 2007-01
• Study Start: 2007-04
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard	Standard sodium dialysate	Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
Automated profiled	Automated sodium profiling in endogenous hemodiafiltration	Automate sodium profiling in endogenous hemodiafiltration

Primary Outcome Measures

Name	Time	Method
Number of dialysis complicated by at least one hypotension	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 Outcome Measures

Name	Time	Method
Blood Pressure Intradialytic symptoms	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.

Trial Locations

Locations (12)

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat; 🇫🇷 Paris, France

PO Lastaria; 🇮🇹 Foggia, Italy

Ospedale San Giovanni Bosco; 🇮🇹 Torino, Italy

Civil Hospital Bretagne Atlantique; 🇫🇷 Vannes, France

UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Nephrology and Dialysis Unit Ospedali Riuniti; 🇮🇹 Ancona, Italy

Clinic of Internal Medicine; 🇩🇪 Rostock, Germany

Civil Hospital; 🇮🇹 Ciriè, Italy

Hospital Maggiore della Carità; 🇮🇹 Novara, Italy

Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Hospital Val d'Hebron; 🇪🇸 Barcellona, Spain