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Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback (THIRD)

1. april 2010 oppdatert av: Università degli Studi di Brescia

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)

Diabetic nephropathy is becoming the most common primary renal disease in end stage renal disease patients. The prevalence of diabetic patients in dialysis reaches even the 30% of the dialysis population (USRDS) with an incidence rate, in some countries, up to 40%. The 5 years surviving time of diabetic patients in dialysis is about the 20% and, compared to the hypertension and glomerulonephritis complications, still remains the worst. Diabetes is often associated to several comorbid factors such as hypertension, autonomic neuropathy, vasculopathy, metabolic disorders (ketoacidosis, poor glycaemic control), and electrolyte disorders. So, the diabetic patient is fragile, with a rather poor tolerance to dialysis, lack of achievement of dry body weight and inadequate dialysis. In order to gain a more detailed insight into a possible better tolerance to dialysis, arising from the elimination of acetate in dialysate bath (Acetate Free Biofiltration) and from the use of an automatic system to control the blood volume (Blood Volume Control),the investigators would like to investigate the cardiovascular stability and the frequency of intradialytic symptoms in a prospective, randomized, cross-over study.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

55

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Italia
      • Bologna, Italia
        • Hospital "Policlinico S.Orsola-Malpighi"
      • Brescia, Italia
        • Hospital "Spedali Civili"
      • Rimini, Italia
        • Hospital "Degli Infermi"
    • Bologna
      • Imola, Bologna, Italia
        • Hospital "Santa Maria della Scaletta"
    • Brescia
      • Gussago, Brescia, Italia
        • Hospital "Nuovo Ronco"

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: AFB stand alone
Patients are switched in AFB treatment, without blood volume control.
Annen: BD and BVC, AFB
Some patients are randomized into the AFB, the others into the BD and BVC
Andre navn:
  • Biofeedback,Blood Volume Control,Acetate Free Biofiltration
Aktiv komparator: BD and BVC
Patients are switched into bicarbonate dialysis with Blood Volume Control
Annen: BD and BVC, AFB
Some patients are randomized into the AFB, the others into the BD and BVC
Andre navn:
  • Biofeedback,Blood Volume Control,Acetate Free Biofiltration

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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).
Tidsramme: 3 months

The treatment tolerance is measured by the number of intradialytic hypotensive events, defined as:

  • systolic blood pressure less then 90 mmHg;
  • systolic blood pressure more then 25 mmHg to the predialysis value, with hypotensive events requiring therapies;
  • systolic blood pressure less then 90 mmHg with hypotensive events requiring therapies for those patients, which predialysis systolic blood pressure value was 100 mmHg.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 3 months

The evaluation will be done on:

  • frequency of hypotensive events, during dialysis (defined as above);
  • number of nurse interventions (defined as ultrafiltration rate stop, or saline infusion);
  • antihypertensive drugs.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Università degli Studi di Brescia

Etterforskere

  • Studiestol: Giovanni Cancarini, MD, Università of Brescia

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2006

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. mars 2010

Datoer for studieregistrering

Først innsendt

29. mars 2010

Først innsendt som oppfylte QC-kriteriene

1. april 2010

Først lagt ut (Anslag)

2. april 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. april 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2010

Sist bekreftet

1. mars 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • THIRD-01

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