Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Ercan OK, Ege University
ClinicalTrials.gov Identifier:
NCT00411177
First received: December 12, 2006
Last updated: September 6, 2013
Last verified: September 2013

December 12, 2006
September 6, 2013
January 2007
January 2010   (final data collection date for primary outcome measure)
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 ]
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
Complete list of historical versions of study NCT00411177 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
End-Stage Renal Disease
  • Procedure: post-dilution on-line hemodiafiltration
    post-dilution on-line hemodiafiltration, 3 times a week 4 hours
    Other Name: post-dilution on-line hemodiafiltration
  • Procedure: high flux hemodialysis
    High-flux hemodialysis, 3 times a week 4 hours
    Other Name: High-flux hemodialysis
  • Active Comparator: Post-dilution on-line hemodiafiltration
    Post-dilution on-line hemodiafiltration
    Intervention: Procedure: post-dilution on-line hemodiafiltration
  • High-flux hemodialysis
    High-flux hemodialysis
    Intervention: Procedure: high flux hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
782
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00411177
Ege0683
Yes
Ercan OK, Ege University
Ercan OK
Fresenius Medical Care North America
Principal Investigator: Ercan Ok, MD Ege University
Ege University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP