- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01414842
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Bruxelles, Belgien
- Hospital Erasme
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Paris, Frankrig
- Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
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Vannes, Frankrig
- Civil Hospital Bretagne Atlantique
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Ancona, Italien
- Nephrology and Dialysis Unit Ospedali Riuniti
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Bologna, Italien, 40128
- UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
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Ciriè, Italien
- Civil Hospital
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Foggia, Italien
- PO Lastaria
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Novara, Italien
- Hospital Maggiore della Carità
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San Giovanni Rotondo, Italien
- Casa Sollievo della Sofferenza
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Torino, Italien
- Ospedale San Giovanni Bosco
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Barcellona, Spanien
- Hospital Val d'Hebron
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Rostock, Tyskland
- Clinic of Internal Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of dialysis complicated by at least one hypotension
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Blood Pressure Intradialytic symptoms
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Francesco Locatelli, Prof., Azienda Ospedaliera di Lecco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HFR-AE-2006
- HFR-BFBCK0611 (Anden identifikator: AOLecco)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hypotension
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Kliniske forsøg med Standard sodium dialysate
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Rockwell Medical Technologies, Inc.AfsluttetKronisk nyresvigt, der kræver hæmodialyseForenede Stater, Canada
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National University Hospital, SingaporeNational University of SingaporeAfsluttetHypotension | Dialyse AmyloidoseSingapore
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University Hospital, MontpellierRekrutteringAkut nyreskade | NyreerstatningsterapiFrankrig
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Alexandria UniversityIkke rekrutterer endnuDialyse; KomplikationerEgypten
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Shanghai Jiao Tong University School of MedicineAfsluttetSlutstadie nyresygdomKina
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Yale UniversityAfsluttetHæmodialyse | HypotensionForenede Stater