Clinical trial NCT00411177: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
First posted: 2006-12-13
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Post-dilution on-line hemodiafiltration,
2. 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 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

Primary outcomes:
measure: composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
timeFrame: two years
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: two years
measure: hospitalization rate
timeFrame: two years
measure: intradialytic complications including hypotension and cramp
timeFrame: two years
measure: health-related quality of life, depression burden, cognitive function
timeFrame: two years
measure: required medications
timeFrame: two years
measure: 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
timeFrame: two years
measure: postdialysis total body water determined by bioimpedance analysis
timeFrame: two years
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine
state: Izmir
city: Adana
country: Turkey
facility: FMC Clinics Turkey
Study officials:
affiliation: Ege University
name: Ercan Ok, MD
role: PRINCIPAL_INVESTIGATOR
References: