- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01098149
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)
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv 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
Andra namn:
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Aktiv 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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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).
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: 3 months
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The evaluation will be done on:
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3 months
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Samarbetspartners och utredare
Utredare
- Studiestol: Giovanni Cancarini, MD, Università of Brescia
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- THIRD-01
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