Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411177
• Other study ID #: Ege0683
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2006
• Last updated: September 6, 2013
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: September 2013
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 782
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
• high flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours

Locations

Country	Name	City	State
Turkey	FMC Clinics Turkey	Adana
Turkey	Ege University School of Medicine	Bornova	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ercan OK	Fresenius Medical Care North America

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.		two years	No
Secondary	cardiovascular mortality		two years	No
Secondary	hospitalization rate		two years	No
Secondary	intradialytic complications including hypotension and cramp		two years	No
Secondary	health-related quality of life, depression burden, cognitive function		two years	No
Secondary	required medications		two years	No
Secondary	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 ß-2 microglobulin		two years	No
Secondary	postdialysis total body water determined by bioimpedance analysis		two years	No