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Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
post-dilution on-line hemodiafiltration
high flux hemodialysis
Sponsored by
Ercan OK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, on-line hemodiafiltration, arterial stiffness, inflammation, life quality, left ventricular hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • older than 18 years
  • on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
  • willingness to participate in the study with a written informed consent

Exclusion Criteria:

  • To be scheduled for living donor renal transplantation
  • To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
  • Pregnancy or lactating
  • Current requirement for HD more than three times per week due to medical comorbidity
  • GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
  • Use of temporary catheter
  • Insufficient vascular access (blood flow rate lower than 250 ml/min)
  • Mental incompetence

Sites / Locations

  • Ege University School of Medicine
  • FMC Clinics Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Post-dilution on-line hemodiafiltration

High-flux hemodialysis

Arm Description

Post-dilution on-line hemodiafiltration

High-flux hemodialysis

Outcomes

Primary Outcome Measures

composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.

Secondary Outcome Measures

cardiovascular mortality
hospitalization rate
intradialytic complications including hypotension and cramp
health-related quality of life, depression burden, cognitive function
required medications
changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
postdialysis total body water determined by bioimpedance analysis

Full Information

First Posted
December 12, 2006
Last Updated
September 6, 2013
Sponsor
Ercan OK
Collaborators
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT00411177
Brief Title
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
Official Title
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ercan OK
Collaborators
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.
Detailed Description
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups: Post-dilution on-line hemodiafiltration, High-flux hemodialysis. In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions. Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, on-line hemodiafiltration, arterial stiffness, inflammation, life quality, left ventricular hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
782 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-dilution on-line hemodiafiltration
Arm Type
Active Comparator
Arm Description
Post-dilution on-line hemodiafiltration
Arm Title
High-flux hemodialysis
Arm Type
Other
Arm Description
High-flux hemodialysis
Intervention Type
Procedure
Intervention Name(s)
post-dilution on-line hemodiafiltration
Intervention Description
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
Intervention Type
Procedure
Intervention Name(s)
high flux hemodialysis
Other Intervention Name(s)
High-flux hemodialysis
Intervention Description
High-flux hemodialysis, 3 times a week 4 hours
Primary Outcome Measure Information:
Title
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
Time Frame
two years
Secondary Outcome Measure Information:
Title
cardiovascular mortality
Time Frame
two years
Title
hospitalization rate
Time Frame
two years
Title
intradialytic complications including hypotension and cramp
Time Frame
two years
Title
health-related quality of life, depression burden, cognitive function
Time Frame
two years
Title
required medications
Time Frame
two years
Title
changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Time Frame
two years
Title
postdialysis total body water determined by bioimpedance analysis
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: older than 18 years on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2 willingness to participate in the study with a written informed consent Exclusion Criteria: To be scheduled for living donor renal transplantation To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease Pregnancy or lactating Current requirement for HD more than three times per week due to medical comorbidity GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours Use of temporary catheter Insufficient vascular access (blood flow rate lower than 250 ml/min) Mental incompetence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Ok, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University School of Medicine
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
FMC Clinics Turkey
City
Adana
ZIP/Postal Code
01000
Country
Turkey

12. IPD Sharing Statement

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Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

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