Comparison of Post-Dilution on-Line Hemodiafiltration and Hemodialysis - Full Text View

Sponsors and Collaborators:	Ege University Fresenius Medical Care North America
Information provided by:	Ege University
ClinicalTrials.gov Identifier:	NCT00411177

Purpose

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.

Condition	Intervention	Phase
End-Stage Renal Disease Hemodialysis	Procedure: on-line hemodiafiltration Procedure: high flux hemodialysis	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Post-Dilution on-Line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)

Further study details as provided by Ege University:

Primary Outcome Measures:

composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization. [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cardiovascular mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
hospitalization rate [ Time Frame: two years ] [ Designated as safety issue: No ]
intradialytic complications including hypotension and cramp [ Time Frame: two years ] [ Designated as safety issue: No ]
health-related quality of life, depression burden, cognitive function [ Time Frame: two years ] [ Designated as safety issue: No ]
required medications [ Time Frame: two years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
postdialysis total body water determined by bioimpedance analysis [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	780
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Post-dilution on-line hemodiafiltration	Procedure: on-line hemodiafiltration on-line hemodiafiltration 3 times a week 4 hours
2 High-flux hemodialysis	Procedure: high flux hemodialysis high flux hemodialysis 3 times a week 4 hours

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411177

Locations

Turkey
FMC Clinics Turkey
Adana, Turkey, 01000
Turkey, Izmir
Ege University School of Medicine
Bornova, Izmir, Turkey, 35100

Sponsors and Collaborators

Ege University

Fresenius Medical Care North America

Investigators

Principal Investigator:

Ercan Ok, MD

Ege University

More Information

No publications provided

Responsible Party:	Fresenius Medical Care ( Fresenius Medical Care )
Study ID Numbers:	Ege0683
Study First Received:	December 12, 2006
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00411177 History of Changes
Health Authority:	Turkey: Ministry of Health

Keywords provided by Ege University:

end-stage renal disease
hemodialysis
cardiovascular morbidity and mortality
high flux dialyser
on-line hemodiafiltration

arterial stiffness
inflammation
life quality
left ventricular hypertrophy

Study placed in the following topic categories:

Hypertrophy, Left Ventricular
Renal Insufficiency
Hypertrophy
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Quality of Life
Kidney Diseases
Kidney Failure
Inflammation

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009