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

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ClinicalTrials.gov Identifier: NCT00694031
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : February 28, 2014
Societat Catalana de Nefrologia
Information provided by (Responsible Party):
Francisco Maduell, Hospital Clinic of Barcelona

Brief Summary:
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 or disease Intervention/treatment Phase
Hemodialysis Procedure: Hemodialysis Procedure: On-line hemodiafiltration Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 906 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: A
Procedure: Hemodialysis
3 times per week

Experimental: B
On-line hemodiafiltration
Procedure: On-line hemodiafiltration
3 times per week

Primary Outcome Measures :
  1. Survival [ Time Frame: 36 months ]

Information from the National Library of Medicine

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

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

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

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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
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Responsible Party: Francisco Maduell, Dr, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00694031    
Other Study ID Numbers: ESHOL
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: June 2012
Keywords provided by Francisco Maduell, Hospital Clinic of Barcelona:
Convective therapies
On-line Hemodiafiltration
Dialysis Adequacy
Age 18 or older
Undergoing hemodialysis