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| ID | Type | Description | Link |
|---|---|---|---|
| HFR-BFBCK0611 | Other Identifier | AOLecco |
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| Name | Class |
|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| Centre Pasteur Vallery Radot | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration |
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| Automated profiled | Experimental | Automate sodium profiling in endogenous hemodiafiltration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated sodium profiling in endogenous hemodiafiltration | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Locatelli, Prof. | Azienda Ospedaliera di Lecco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Erasme | Brussels | Belgium | ||||
| Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39498822 | Derived | Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard sodium dialysate | Device | Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration |
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| Paris |
| France |
| Civil Hospital Bretagne Atlantique | Vannes | France |
| Clinic of Internal Medicine | Rostock | Germany |
| Nephrology and Dialysis Unit Ospedali Riuniti | Ancona | Italy |
| UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi | Bologna | 40128 | Italy |
| Civil Hospital | Cirié | 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 |
| Hospital Val d'Hebron | Barcelona | Spain |