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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

December 19, 2006
August 3, 2009
December 2006
February 2008   (final data collection date for primary outcome measure)
total mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Composite of total mortality and hospitalization rate
Complete list of historical versions of study NCT00413803 on ClinicalTrials.gov Archive Site
  • 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 ]
  • cardiovascular mortality
  • changes in health-related quality of life, depression burden, cognitive function
  • vascular access patency
  • required medications
  • total cost
  • changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Not Provided
Not Provided
 
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End-Stage Renal Disease
  • Hemodialysis
  • Procedure: 4-hour thrice weekly in center hemodialysis
    conventional hemodialysis
  • Procedure: 8-hour thrice weekly in center hemodialysis
    long dialysis
  • 1
    Four-hour dialysis session, blood flow rate 300-400 ml/min
    Intervention: Procedure: 4-hour thrice weekly in center hemodialysis
  • Active Comparator: 2
    Eight-hours dialysis session, blood flow rate 200-250 ml/min
    Intervention: Procedure: 8-hour thrice weekly in center hemodialysis
Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
February 2008
February 2008   (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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00413803
06-5.1/8
Yes
Fresenius Medical Care
Ege University
Fresenius Medical Care North America
Principal Investigator: Ercan Ok, MD Ege University
Ege University
August 2009

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