CClinicalTrials.gg
Sign In
CompletedNCT01583309ECTDPUpdated Apr 24, 2012

Effects of Convective Therapies in Dialysis Patients

A Phase 3 interventional study of online pre-dilution hemofiltration and online pre-dilution hemodiafiltration in Uremia, sponsored by A. Manzoni Hospital. Completed at 27 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-24.

Sponsored by A. Manzoni Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.

To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.

02

Conditions studied

  • Uremia

Browse trials for

Keywords

  • blood pressure
  • cardiovascular instability
  • symptomatic hypotension
  • online hemofiltration
  • online hemodiafiltration
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Dialysis patients aged 18-80 years
  • thrice-weekly HD or HDF for at least 6 months
  • body weight less or equal to 90 Kg
  • stable clinical condition
  • written consent

Exclusion criteria

Exclusion Criteria:

  • infections
  • malignancies
  • active systemic diseases
  • active hepatitis or cirrhosis
  • unstable diabetes
  • diuresis higher than 200 ml/24h
  • dysfunction of vascular access
  • blood flow rate less than 300 ml/min
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (actual)

Study arms

  • No intervention
    low-flux hemodialysis
  • Experimental
    online pre-dilution hemofiltration

    Procedure: online pre-dilution hemofiltration

  • Experimental
    online pre-dilution hemodiafiltration

    Procedure: online pre-dilution hemodiafiltration

Interventions

  • Procedureonline pre-dilution hemofiltration

    Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one

    Also known as: online pre-dilution hemofiltration Technique

  • Procedureonline pre-dilution hemodiafiltration

    Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.

    Also known as: online pre-dilution hemodiafiltration Technique

05

What researchers measure

Primary outcomes

  1. Intradialytic symptomatic hypotension

    Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention

    Time frame: all dialysis sessions, three per week, for 2 years

Secondary outcomes

  1. Resistance to erythropoiesis-stimulating agents

    Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL\*body wheight in kg)

    Time frame: Monthly for 2 years

  2. Calcium-phosphate metabolism

    Outcome measures: phosphatemia, calcemia and PTH

    Time frame: Monthly for 2 years

  3. Beta2 microglobulin

    Time frame: Every six months for 2 years

06

Study locations

27 sites
  • Ospedale S.Marta S.Venera
    Acireale (CT), Italy
  • Ospedale F. Miulli
    Acquaviva delle Fonti, Italy
  • Ospedale Civile
    Alghero, Italy
  • Ospedale regionale di Aosta
    Aosta, Italy
  • Ospedale degli Infermi
    Biella, Italy
  • Ospedale SS. Trinità ASL 8
    Cagliari, Italy
  • S. Michele Hospital
    Cagliari, Italy
  • Ospedale Civile "P. Merlo"
    La maddalena, Italy
  • Alessandro Manzoni Hospital
    Lecco, Italy
  • Ospedale "C. POMA"
    Mantova, Italy
  • T. EVOLI
    Melito Porto Salvo, Italy
  • Ospedale dell'Angelo
    Mestre, Italy
  • Policlinico Multimedica IRCCS
    Milano, Italy
  • Federico II
    Napoli, Italy
  • Ospedale San Francesco
    Nuoro, Italy
  • San Giovanni di Dio
    Olbia, Italy
  • Ospedale Antonio Segni
    Ozieri, Italy
  • Ospedale Maggiore
    Parma, Italy
  • Fondazione Maugeri
    Pavia, Italy
  • Ospedale " E. AGNELLI "
    Pinerolo, Italy
  • Dipartimento territoriale ASL 8
    Quartu Sant'Elena, Italy
  • Ospedale S.Maria delle Croci
    Ravenna, Italy
  • Azienda Ospedaliera "Bianchi Melacrino Morelli,"
    Reggio Calabria, Italy
  • Ospedale Bolognini
    Seriate, Italy
  • Ospedale Agostino Landolfi
    Solofra, Italy
  • Ospedale San Camillo
    Sorgono, Italy
  • ASL 2 Olbia - P.O. "P. Dettori",
    Tempio Pausania, Italy
07

References and documents

Publications

  • Bolasco P, Altieri P, Andrulli S, Basile C, Di Filippo S, Feriani M, Pedrini L, Santoro A, Zoccali C, Sau G, Locatelli F. Convection versus diffusion in dialysis: an Italian prospective multicentre study. Nephrol Dial Transplant. 2003 Aug;18 Suppl 7:vii50-4; discussion vii59-62. doi: 10.1093/ndt/gfg1080. PubMed 12953031 ↗
  • Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc Nephrol. 2010 Oct;21(10):1798-807. doi: 10.1681/ASN.2010030280. Epub 2010 Sep 2. PubMed 20813866 ↗
  • Locatelli F, Altieri P, Andrulli S, Sau G, Bolasco P, Pedrini LA, Basile C, David S, Gazzanelli L, Tampieri G, Isola E, Marzolla O, Memoli B, Ganadu M, Reina E, Bertoli S, Ferrara R, Casu D, Logias F, Tarchini R, Mattana G, Passaghe M, Fundoni G, Villa G, Di Iorio BR, Pontoriero G, Zoccali C. Phosphate levels in patients treated with low-flux haemodialysis, pre-dilution haemofiltration and haemodiafiltration: post hoc analysis of a multicentre, randomized and controlled trial. Nephrol Dial Transplant. 2014 Jun;29(6):1239-46. doi: 10.1093/ndt/gfu031. Epub 2014 Feb 20. PubMed 24557989 ↗
08

Registry details

Key details

Study ID
NCT01583309
Lead sponsor
A. Manzoni Hospital
Responsible party
Prof. Francesco Locatelli (Professor Francesco Locatelli, A. Manzoni Hospital) — Principal investigator
First posted
Apr 24, 2012
Start date
Nov 2003
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Apr 24, 2012

Study contacts

Francesco Locatelli, Professor
study chair · A. Manzoni Hospital, Lecco - Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Uremia→

Other studies from this sponsor

A. Manzoni Hospital

Start the discussion