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

This study has been completed.
Sponsor:
Collaborator:
Societat Catalana de Nefrologia
Information provided by (Responsible Party):
Francisco Maduell, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00694031
First received: June 5, 2008
Last updated: February 27, 2014
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Francisco Maduell, Dr, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00694031     History of Changes
Other Study ID Numbers: ESHOL
Study First Received: June 5, 2008
Last Updated: February 27, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Mortality
Convective therapies
On-line Hemodiafiltration
Dialysis Adequacy
Age 18 or older
Undergoing hemodialysis

ClinicalTrials.gov processed this record on July 23, 2014