Effects of Convective Therapies in Dialysis Patients (ECTDP)
This study has been completed.
Sponsor:
A. Manzoni Hospital
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01583309
First received: April 17, 2012
Last updated: April 23, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uremia |
Procedure: online pre-dilution hemofiltration Procedure: online pre-dilution hemodiafiltration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Convective Therapies in Dialysis Patients |
Resource links provided by NLM:
Further study details as provided by A. Manzoni Hospital:
Primary Outcome Measures:
- Intradialytic symptomatic hypotension [ Time Frame: all dialysis sessions, three per week, for 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: Monthly for 2 years ] [ Designated as safety issue: No ]Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg)
- Calcium-phosphate metabolism [ Time Frame: Monthly for 2 years ] [ Designated as safety issue: No ]Outcome measures: phosphatemia, calcemia and PTH
- Beta2 microglobulin [ Time Frame: Every six months for 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 146 |
| Study Start Date: | November 2003 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: low-flux hemodialysis | |
| Experimental: online pre-dilution hemofiltration |
Procedure: online pre-dilution hemofiltration
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
Other Name: online pre-dilution hemofiltration Technique
|
| Experimental: online pre-dilution hemodiafiltration |
Procedure: online 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.
Other Name: online pre-dilution hemodiafiltration Technique
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583309
Locations
| Italy | |
| 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 | |
Sponsors and Collaborators
A. Manzoni Hospital
Investigators
| Study Chair: | Francesco Locatelli, Professor | A. Manzoni Hospital, Lecco - Italy |
More Information
Publications:
| Responsible Party: | Prof. Francesco Locatelli, Professor Francesco Locatelli, A. Manzoni Hospital |
| ClinicalTrials.gov Identifier: | NCT01583309 History of Changes |
| Other Study ID Numbers: | CONVESTUDY |
| Study First Received: | April 17, 2012 |
| Last Updated: | April 23, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by A. Manzoni Hospital:
|
blood pressure cardiovascular instability symptomatic hypotension online hemofiltration online hemodiafiltration |
Additional relevant MeSH terms:
|
Uremia Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013