Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT00413803
First received: December 19, 2006
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.


Condition Intervention Phase
End-Stage Renal Disease
Hemodialysis
Procedure: 4-hour thrice weekly in center hemodialysis
Procedure: 8-hour thrice weekly in center hemodialysis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • total mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
  • changes in health-related quality of life, depression burden, cognitive function [ Time Frame: one year ] [ Designated as safety issue: No ]
  • required medications [ Time Frame: one year ] [ Designated as safety issue: No ]
  • total cost [ Time Frame: one year ] [ Designated as safety issue: No ]
  • changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • hospitalization rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Vascular access patency [ Time Frame: one year ] [ Designated as safety issue: No ]
  • post-dialysis body weight and total body water [ Time Frame: one year ] [ Designated as safety issue: No ]
  • arrythmia episodes determined by Holter-ECG [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Four-hour dialysis session, blood flow rate 300-400 ml/min
Procedure: 4-hour thrice weekly in center hemodialysis
conventional hemodialysis
Active Comparator: 2
Eight-hours dialysis session, blood flow rate 200-250 ml/min
Procedure: 8-hour thrice weekly in center hemodialysis
long dialysis

Detailed Description:

The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:

  1. Four-hour dialysis session, blood flow rate 300-400 ml/min
  2. Eight-hours dialysis session, blood flow rate 200-250 ml/min

Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.

  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
  • Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
  • 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: NCT00413803

Locations
Turkey
FMC Turkey Clinics
Adana, Turkey, 01100
Ege University School of Medicine Nephrology Department
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Fresenius Medical Care North America
Investigators
Principal Investigator: Ercan Ok, MD Ege University
  More Information

No publications provided by Ege University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fresenius Medical Care
ClinicalTrials.gov Identifier: NCT00413803     History of Changes
Other Study ID Numbers: 06-5.1/8
Study First Received: December 19, 2006
Last Updated: August 3, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Ege University:
Hemodialysis
Nocturnal dialysis
Cardiovascular disease
Quality of Life
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 26, 2014