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Effects of Convective Therapies in Dialysis Patients (ECTDP)

Primary Purpose

Uremia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
online pre-dilution hemofiltration
online pre-dilution hemodiafiltration
Sponsored by
A. Manzoni Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia focused on measuring blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Ospedale S.Marta S.Venera
  • Ospedale F. Miulli
  • Ospedale Civile
  • Ospedale regionale di Aosta
  • Ospedale degli Infermi
  • Ospedale SS. Trinità ASL 8
  • S. Michele Hospital
  • Ospedale Civile "P. Merlo"
  • Alessandro Manzoni Hospital
  • Ospedale "C. POMA"
  • T. EVOLI
  • Ospedale dell'Angelo
  • Policlinico Multimedica IRCCS
  • Federico II
  • Ospedale San Francesco
  • San Giovanni di Dio
  • Ospedale Antonio Segni
  • Ospedale Maggiore
  • Fondazione Maugeri
  • Ospedale " E. AGNELLI "
  • Dipartimento territoriale ASL 8
  • Ospedale S.Maria delle Croci
  • Azienda Ospedaliera "Bianchi Melacrino Morelli,"
  • Ospedale Bolognini
  • Ospedale Agostino Landolfi
  • Ospedale San Camillo
  • ASL 2 Olbia - P.O. "P. Dettori",

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

low-flux hemodialysis

online pre-dilution hemofiltration

online pre-dilution hemodiafiltration

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Calcium-phosphate metabolism
Outcome measures: phosphatemia, calcemia and PTH
Beta2 microglobulin

Full Information

First Posted
April 17, 2012
Last Updated
April 23, 2012
Sponsor
A. Manzoni Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01583309
Brief Title
Effects of Convective Therapies in Dialysis Patients
Acronym
ECTDP
Official Title
Effects of Convective Therapies in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A. Manzoni Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-flux hemodialysis
Arm Type
No Intervention
Arm Title
online pre-dilution hemofiltration
Arm Type
Experimental
Arm Title
online pre-dilution hemodiafiltration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
online pre-dilution hemofiltration
Other Intervention Name(s)
online pre-dilution hemofiltration Technique
Intervention Description
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
Intervention Type
Procedure
Intervention Name(s)
online pre-dilution hemodiafiltration
Other Intervention Name(s)
online pre-dilution hemodiafiltration Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intradialytic symptomatic hypotension
Description
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 Outcome Measure Information:
Title
Resistance to erythropoiesis-stimulating agents
Description
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
Title
Calcium-phosphate metabolism
Description
Outcome measures: phosphatemia, calcemia and PTH
Time Frame
Monthly for 2 years
Title
Beta2 microglobulin
Time Frame
Every six months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Locatelli, Professor
Organizational Affiliation
A. Manzoni Hospital, Lecco - Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale S.Marta S.Venera
City
Acireale (CT)
Country
Italy
Facility Name
Ospedale F. Miulli
City
Acquaviva delle Fonti
Country
Italy
Facility Name
Ospedale Civile
City
Alghero
Country
Italy
Facility Name
Ospedale regionale di Aosta
City
Aosta
Country
Italy
Facility Name
Ospedale degli Infermi
City
Biella
Country
Italy
Facility Name
Ospedale SS. Trinità ASL 8
City
Cagliari
Country
Italy
Facility Name
S. Michele Hospital
City
Cagliari
Country
Italy
Facility Name
Ospedale Civile "P. Merlo"
City
La maddalena
Country
Italy
Facility Name
Alessandro Manzoni Hospital
City
Lecco
Country
Italy
Facility Name
Ospedale "C. POMA"
City
Mantova
Country
Italy
Facility Name
T. EVOLI
City
Melito Porto Salvo
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Mestre
Country
Italy
Facility Name
Policlinico Multimedica IRCCS
City
Milano
Country
Italy
Facility Name
Federico II
City
Napoli
Country
Italy
Facility Name
Ospedale San Francesco
City
Nuoro
Country
Italy
Facility Name
San Giovanni di Dio
City
Olbia
Country
Italy
Facility Name
Ospedale Antonio Segni
City
Ozieri
Country
Italy
Facility Name
Ospedale Maggiore
City
Parma
Country
Italy
Facility Name
Fondazione Maugeri
City
Pavia
Country
Italy
Facility Name
Ospedale " E. AGNELLI "
City
Pinerolo
Country
Italy
Facility Name
Dipartimento territoriale ASL 8
City
Quartu Sant'Elena
Country
Italy
Facility Name
Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Azienda Ospedaliera "Bianchi Melacrino Morelli,"
City
Reggio Calabria
Country
Italy
Facility Name
Ospedale Bolognini
City
Seriate
Country
Italy
Facility Name
Ospedale Agostino Landolfi
City
Solofra
Country
Italy
Facility Name
Ospedale San Camillo
City
Sorgono
Country
Italy
Facility Name
ASL 2 Olbia - P.O. "P. Dettori",
City
Tempio Pausania
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12953031
Citation
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.
Results Reference
background
PubMed Identifier
20813866
Citation
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.
Results Reference
result
PubMed Identifier
24557989
Citation
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.
Results Reference
derived

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Effects of Convective Therapies in Dialysis Patients

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