HFR A-equilibrium on Cardiovascular Stability (AIMS)
Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Bruxelles, België
- Hospital Erasme
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Rostock, Duitsland
- Clinic of Internal Medicine
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Paris, Frankrijk
- Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
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Vannes, Frankrijk
- Civil Hospital Bretagne Atlantique
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Ancona, Italië
- Nephrology and Dialysis Unit Ospedali Riuniti
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Bologna, Italië, 40128
- UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
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Ciriè, Italië
- Civil Hospital
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Foggia, Italië
- PO Lastaria
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Novara, Italië
- Hospital Maggiore della Carità
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San Giovanni Rotondo, Italië
- Casa Sollievo Della Sofferenza
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Torino, Italië
- Ospedale San Giovanni Bosco
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Barcellona, Spanje
- Hospital Val d'Hebron
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Standard
Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
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Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
Andere namen:
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Experimenteel: Automated profiled
Automate sodium profiling in endogenous hemodiafiltration
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of dialysis complicated by at least one hypotension
Tijdsspanne: six months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Blood Pressure Intradialytic symptoms
Tijdsspanne: six months
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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.
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six months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Francesco Locatelli, Prof., Azienda Ospedaliera di Lecco
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HFR-AE-2006
- HFR-BFBCK0611 (Andere identificatie: AOLecco)
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