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

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

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 10, 2008
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Survival [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00694031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survival Study in Patients Undergoing On-line Hemodiafiltration
Official Title  ICMJE A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemodialysis
Intervention  ICMJE
  • Procedure: Hemodialysis
    3 times per week
  • Procedure: On-line hemodiafiltration
    3 times per week
Study Arms  ICMJE
  • Active Comparator: A
    Hemodialysis
    Intervention: Procedure: Hemodialysis
  • Experimental: B
    On-line hemodiafiltration
    Intervention: Procedure: On-line hemodiafiltration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
906
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2008)
800
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694031
Other Study ID Numbers  ICMJE ESHOL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Maduell, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Societat Catalana de Nefrologia
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP