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
  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
Procedure: post-dilution on-line hemodiafiltration
Procedure: high flux hemodialysis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)

Resource links provided by NLM:


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 ]

Enrollment: 782
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Post-dilution on-line hemodiafiltration
Post-dilution on-line hemodiafiltration
Procedure: post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
Other Name: post-dilution on-line hemodiafiltration
High-flux hemodialysis
High-flux hemodialysis
Procedure: high flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours
Other Name: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Turkey
Ege University School of Medicine
Bornova, Izmir, Turkey, 35100
FMC Clinics Turkey
Adana, Turkey, 01000
Sponsors and Collaborators
Ercan OK
Fresenius Medical Care North America
Investigators
Principal Investigator: Ercan Ok, MD Ege University
  More Information

No publications provided

Responsible Party: Ercan OK, professor, Ege University
ClinicalTrials.gov Identifier: NCT00411177     History of Changes
Other Study ID Numbers: Ege0683
Study First Received: December 12, 2006
Last Updated: September 6, 2013
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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014