Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback (THIRD)
Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: a Prospective Randomized,Cross-over Multicenter Study Between Bicarbonate Dialysis (BD) and Blood Volume Controlled Acetate-Free Biofiltration (BVC-AFB)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Acetate-Free-Biofiltration (AFB) was proved to be a technique suitable to treat critical patients, such as elders and diabetics, because of frequency reduction of hypotensive episodes and symptoms during the treatment and a better control to metabolic aspects (such as metabolic acidosis).
The Blood Volume Control (BVC) is a tool, that allows to improve the cardiovascular tolerance to the treatment, especially in hypotension-prone patients, appearing promising in the correction of the arterial hypertension induced by the hydro-saline overload.
The use of BVC in AFB has been tested to verify the behaviour of the kinetics of electrolyte (in particular of bicarbonate) and it has got good results, in terms of a further improvement in treatment tolerance, for critical patients However, this therapy (AFB+BVC) was not yet evaluated as the dialysis tolerance improvement in diabetics concern, nor the relative contribution given by each factor in achieving this result.
The study, 9 months long, is aimed to verify the treatment tolerance of insulin requiring diabetic patients, by using standard bicarbonate dialysis (BD), or Acetate Free Biofiltration (AFB) and/or a Blood Volume Control(BVC). The study is divided in three phases: the first one, three months long, is the baseline in standard bicarbonate dialysis, then all the patients are shifted to AFB with BVC, for other three months, while the last three months long phase, after a randomization, has the aim to identify the relative contribution of each factor (absence of acetate in the bath or BVC) in the treatment tolerance improvement(if any). The treatment tolerance will be evaluated considering the frequency of intradialytic hypotensive events.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Bologna, Italien
- Hospital "Policlinico S.Orsola-Malpighi"
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Brescia, Italien
- Hospital "Spedali Civili"
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Rimini, Italien
- Hospital "Degli Infermi"
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Bologna
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Imola, Bologna, Italien
- Hospital "Santa Maria della Scaletta"
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Brescia
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Gussago, Brescia, Italien
- Hospital "Nuovo Ronco"
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- End stage renal disease patients
- Patients affected by diabetic nephropathy with insulin therapy, for, at least, 6 months
- Patients with renal replacement therapy with haemodialysis three time a week, for, at least, 6 months.
- Age between 18 and 85 years
Exclusion Criteria:
- Patients affected by neoplasm and/or mental illness
- Patients with residual diuresis > 500 ml/die;
- Patients in single needle bicarbonate dialysis.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: AFB stand alone
Patients are switched in AFB treatment, without blood volume control.
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Some patients are randomized into the AFB, the others into the BD and BVC
Andere Namen:
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Aktiver Komparator: BD and BVC
Patients are switched into bicarbonate dialysis with Blood Volume Control
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Some patients are randomized into the AFB, the others into the BD and BVC
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Investigate a possible better tolerance to dialysis, eliminating acetate in the dialysate bath, with AFB treatment, and using, at the same time, the automatic blood volume control (BVC).
Zeitfenster: 3 months
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The treatment tolerance is measured by the number of intradialytic hypotensive events, defined as:
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3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The secondary outcome measure is to evaluate the relative efficiency of each factor (AFB in the bath and blood volume control) to reach this result.
Zeitfenster: 3 months
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The evaluation will be done on:
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3 months
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Giovanni Cancarini, MD, Università of Brescia
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Movilli E, Camerini C, Zein H, D'Avolio G, Sandrini M, Strada A, Maiorca R. A prospective comparison of bicarbonate dialysis, hemodiafiltration, and acetate-free biofiltration in the elderly. Am J Kidney Dis. 1996 Apr;27(4):541-7. doi: 10.1016/s0272-6386(96)90165-1.
- Verzetti G, Navino C, Bolzani R, Galli G, Panzetta G. Acetate-free biofiltration versus bicarbonate haemodialysis in the treatment of patients with diabetic nephropathy: a cross-over multicentric study. Nephrol Dial Transplant. 1998 Apr;13(4):955-61. doi: 10.1093/ndt/13.4.955.
- Santoro A, Mancini E, Basile C, Amoroso L, Di Giulio S, Usberti M, Colasanti G, Verzetti G, Rocco A, Imbasciati E, Panzetta G, Bolzani R, Grandi F, Polacchini M. Blood volume controlled hemodialysis in hypotension-prone patients: a randomized, multicenter controlled trial. Kidney Int. 2002 Sep;62(3):1034-45. doi: 10.1046/j.1523-1755.2002.00511.x.
- Ronco C, Brendolan A, Milan M, Rodeghiero MP, Zanella M, La Greca G. Impact of biofeedback-induced cardiovascular stability on hemodialysis tolerance and efficiency. Kidney Int. 2000 Aug;58(2):800-8. doi: 10.1046/j.1523-1755.2000.00229.x.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- THIRD-01
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