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

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Ercan OK, Ege University
ClinicalTrials.gov Identifier:
NCT00295191
First received: February 22, 2006
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
End-stage Renal Disease
Hemodialysis
Procedure: high-flux membrane
Procedure: low-flux membrane
Procedure: conventional dialysate
Procedure: ultrapure dialysate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall mortality [ Time Frame: three years ] [ Designated as safety issue: No ]
  • progression of coronary artery calcification [ Time Frame: three years ] [ Designated as safety issue: No ]
  • progression of carotid artery intima-media thickness [ Time Frame: three years ] [ Designated as safety issue: No ]
  • changes in post-dialysis body weight [ Time Frame: three years ] [ Designated as safety issue: No ]
  • changes in upper mid-arm circumference [ Time Frame: three years ] [ Designated as safety issue: No ]
  • changes in hematocrit and related rHu-EPO doses [ Time Frame: three years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 704
Study Start Date: November 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
high-flux dialyser
Procedure: high-flux membrane
high-flux dialyser
Active Comparator: 2
low-flux dialyser
Procedure: low-flux membrane
low-flux dialyser
Active Comparator: 3
conventional dialysate
Procedure: conventional dialysate
conventional dialysate
Active Comparator: 4
ultrapure dialysate
Procedure: ultrapure dialysate
ultrapure dialysate

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295191

Locations
Turkey
FMC Clinics
Bornova, Izmir, Turkey, 35100
Ege University School of Medicine
Bornova-Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Fresenius Medical Care North America
Investigators
Principal Investigator: Ercan Ok, M.D Ege University School of Medicine Nephrology Department
  More Information

No publications provided

Responsible Party: Ercan OK, Principal Investigator, Ege University
ClinicalTrials.gov Identifier: NCT00295191     History of Changes
Other Study ID Numbers: EGE99803466003
Study First Received: February 22, 2006
Last Updated: October 3, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Ege University:
end-stage renal disease
hemodialysis
cardiovascular morbidity and mortality
high flux dialyser
ultrapure dialysate
coronary vascular calcifications
carotid intima-media thickness
atherosclerosis

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

ClinicalTrials.gov processed this record on April 16, 2014