NCT00694031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
906

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 28, 2014

Status Verified

June 1, 2012

Enrollment Period

4.7 years

First QC Date

June 5, 2008

Last Update Submit

February 27, 2014

Conditions

Hemodialysis

Keywords

MortalityConvective therapiesOn-line HemodiafiltrationDialysis AdequacyAge 18 or olderUndergoing hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Survival

    36 months

Study Arms (2)

A

ACTIVE COMPARATOR

Hemodialysis

Procedure: Hemodialysis

B

EXPERIMENTAL

On-line hemodiafiltration

Procedure: On-line hemodiafiltration

Interventions

HemodialysisPROCEDURE

3 times per week

A
On-line hemodiafiltrationPROCEDURE

3 times per week

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic inflammatory diseases
  • Liver cirrhosis
  • Malignancies
  • Chronic immunosuppressant or antiinflammatory use
  • Dialysis through temporary catheter or single puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

CSU Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

  • Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. doi: 10.5301/jn.2010.386.

    PMID: 20602331BACKGROUND

  • Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.

    PMID: 23411788BACKGROUND

MeSH Terms

Interventions

Renal Dialysis

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 10, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 28, 2014

Record last verified: 2012-06

Locations

ES(2)