Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)

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.

Study Overview

• Status: Completed
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Procedure: post-dilution on-line hemodiafiltration; Procedure: high flux hemodialysis

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.

• Study Type: Interventional
• Enrollment (Actual): 782
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Post-dilution on-line hemodiafiltration	Procedure: post-dilution on-line hemodiafiltration; post-dilution on-line hemodiafiltration, 3 times a week 4 hours
Other: High-flux hemodialysis	Procedure: high flux hemodialysis; High-flux hemodialysis, 3 times a week 4 hours; Other Names: High-flux hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
cardiovascular mortality	two years
hospitalization rate	two years
intradialytic complications including hypotension and cramp	two years
health-related quality of life, depression burden, cognitive function	two years
required medications	two years
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	two years
postdialysis total body water determined by bioimpedance analysis	two years

Collaborators and Investigators

• Sponsor: Ercan OK
• Collaborators: Fresenius Medical Care North America
• Investigators: Principal Investigator: Ercan Ok, MD, Ege University

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (Estimate): December 13, 2006

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: September 6, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: inflammation; end-stage renal disease; hemodialysis; arterial stiffness; life quality; cardiovascular morbidity and mortality; high flux dialyser; left ventricular hypertrophy; on-line hemodiafiltration
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: Ege0683