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Survival Study in Patients Undergoing On-line Hemodiafiltration (ESHOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694031
First Posted: June 10, 2008
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Societat Catalana de Nefrologia
Information provided by (Responsible Party):
Francisco Maduell, Hospital Clinic of Barcelona
  Purpose
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.

Condition Intervention Phase
Hemodialysis Procedure: Hemodialysis Procedure: On-line hemodiafiltration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration

Resource links provided by NLM:


Further study details as provided by Francisco Maduell, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Survival [ Time Frame: 36 months ]

Enrollment: 906
Study Start Date: May 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Hemodialysis
Procedure: Hemodialysis
3 times per week
Experimental: B
On-line hemodiafiltration
Procedure: On-line hemodiafiltration
3 times per week

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Currently undergoing hemodialysis
  • Clinical stability
  • Stable vascular access

Exclusion Criteria:

  • Chronic inflammatory diseases
  • Liver cirrhosis
  • Malignancies
  • Chronic immunosuppressant or antiinflammatory use
  • Dialysis through temporary catheter or single puncture
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694031


Locations
Spain
CSU Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Societat Catalana de Nefrologia