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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Rostock, Allemagne
- Clinic of Internal Medicine
-
-
-
-
-
Bruxelles, Belgique
- Hospital Erasme
-
-
-
-
-
Barcellona, Espagne
- Hospital Val d'Hebron
-
-
-
-
-
Paris, France
- Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
-
Vannes, France
- Civil Hospital Bretagne Atlantique
-
-
-
-
-
Ancona, Italie
- Nephrology and Dialysis Unit Ospedali Riuniti
-
Bologna, Italie, 40128
- UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
-
Ciriè, Italie
- Civil Hospital
-
Foggia, Italie
- PO Lastaria
-
Novara, Italie
- Hospital Maggiore della Carità
-
San Giovanni Rotondo, Italie
- Casa Sollievo Della Sofferenza
-
Torino, Italie
- Ospedale San Giovanni Bosco
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Standard
Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
|
Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
Autres noms:
|
|
Expérimental: Automated profiled
Automate sodium profiling in endogenous hemodiafiltration
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of dialysis complicated by at least one hypotension
Délai: 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 |
six months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood Pressure Intradialytic symptoms
Délai: 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.
|
six months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Francesco Locatelli, Prof., Azienda Ospedaliera di Lecco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HFR-AE-2006
- HFR-BFBCK0611 (Autre identifiant: AOLecco)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .