We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in HD Patients(EGESTUDY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295191
First Posted: February 23, 2006
Last Update Posted: October 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Ercan OK, Ege University
February 22, 2006
February 23, 2006
October 4, 2011
November 2005
March 2010   (Final data collection date for primary outcome measure)
cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization [ Time Frame: three years ]
  • Composite of
  • cardiovascular mortality
  • myocardial infarction
  • stroke
  • revascularization
  • unstable angina pectoris requiring hospitalization
Complete list of historical versions of study NCT00295191 on ClinicalTrials.gov Archive Site
  • overall mortality [ Time Frame: three years ]
  • progression of coronary artery calcification [ Time Frame: three years ]
  • progression of carotid artery intima-media thickness [ Time Frame: three years ]
  • changes in post-dialysis body weight [ Time Frame: three years ]
  • changes in upper mid-arm circumference [ Time Frame: three years ]
  • changes in hematocrit and related rHu-EPO doses [ Time Frame: three years ]
  • changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin. [ Time Frame: three years ]
  • overall mortality
  • progression of coronary artery calcification
  • progression of carotid artery intima-media thickness
  • changes in post-dialysis body weight
  • changes in upper mid-arm circumference
  • changes in hematocrit and related rHu-EPO doses
  • changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
Not Provided
Not Provided
 
Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in HD Patients(EGESTUDY)
Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study
This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.

This proposed prospective, randomized, controlled study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.

Their beneficial effects may be directly represented by significantly reduced cardiovascular morbidity and mortality. The proposed additional investigations, such as a possible decrease in the progression of coronary artery calcification and carotid artery intima-media thickness, will help us to understand the mechanisms of the expected reduction or serve as surrogate markers of atherosclerosis, in case the benefit of the interventions cannot be proven with statistical significance.

Seven hundred and four hemodialysis patients treated in Ege University Hospital Dialysis Unit and eight FMC Clinics will be enrolled into the study (3-year follow-up; percentage of yearly expected end-point 10%;expected event-free survival rate for control group during three year is 72.9%,a bilateral alpha risk equal to 5%; an 90% power to detect an increase of 15% in event-free survival at the end of 3-year follow-up in favor of the each intervention group). Annual drop-out rate is estimated as %15-20.

It is designed as 2x2 factorial; the cases, first, will be randomized to high flux dialyser and low flux dialyser arms; then, they will be re-randomized to ultra pure (online-produced by using Diasafe and checked by endotoxin measurement) and standard dialysate arms. The study will last three years; an intermediate analysis will be performed at the 18th month.

Primary end-point is the composite of cardiovascular mortality and myocardial infarction, stroke, revascularization, unstable angina pectoris requiring hospitalization (at 18 ad 36th month).

Secondary end-points are overall mortality, progression of coronary artery calcification, progression of carotid artery intima-media thickness, changes in post-dialysis body weight and upper mid-arm circumference, hematocrit and related rHu-EPO doses, changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.

At the 0-18-36 months, coronary artery calcification will be assessed by multi-slice CT and carotid artery intima-media thickness by B-mode ultrasonography. Lipids and CRP will be measured in every three months.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • End-stage Renal Disease
  • Hemodialysis
  • Procedure: high-flux membrane
    high-flux dialyser
  • Procedure: low-flux membrane
    low-flux dialyser
  • Procedure: conventional dialysate
    conventional dialysate
  • Procedure: ultrapure dialysate
    ultrapure dialysate
  • Active Comparator: 1
    high-flux dialyser
    Intervention: Procedure: high-flux membrane
  • Active Comparator: 2
    low-flux dialyser
    Intervention: Procedure: low-flux membrane
  • Active Comparator: 3
    conventional dialysate
    Intervention: Procedure: conventional dialysate
  • Active Comparator: 4
    ultrapure dialysate
    Intervention: Procedure: ultrapure dialysate
Ok ES, Asci G, Toz H, Ritz E, Kircelli F, Sever MS, Ozkahya M, Sipahi S, Dheir H, Bozkurt D, Omer Z, Sahin OZ, Ertilav M, Ok E. Glycated hemoglobin predicts overall and cardiovascular mortality in non-diabetic hemodialysis patients. Clin Nephrol. 2014 Sep;82(3):173-80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
704
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged between 18 and 80 years
  • On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT00295191
EGE99803466003
Yes
Not Provided
Not Provided
Ercan OK, Ege University
Ege University
Fresenius Medical Care North America
Principal Investigator: Ercan Ok, M.D Ege University School of Medicine Nephrology Department
Ege University
October 2011

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