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

Primary Purpose

End-Stage Renal Disease, Hemodialysis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
4-hour thrice weekly in center hemodialysis
8-hour thrice weekly in center hemodialysis
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Hemodialysis, Nocturnal dialysis, Cardiovascular disease, Quality of Life, left ventricular hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FMC Turkey Clinics
  • Ege University School of Medicine Nephrology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

1

2

Arm Description

Four-hour dialysis session, blood flow rate 300-400 ml/min

Eight-hours dialysis session, blood flow rate 200-250 ml/min

Outcomes

Primary Outcome Measures

total mortality

Secondary Outcome Measures

cardiovascular mortality
changes in health-related quality of life, depression burden, cognitive function
required medications
total cost
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
hospitalization rate
Vascular access patency
post-dialysis body weight and total body water
arrythmia episodes determined by Holter-ECG

Full Information

First Posted
December 19, 2006
Last Updated
August 3, 2009
Sponsor
Ege University
Collaborators
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT00413803
Brief Title
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
Official Title
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ege University
Collaborators
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Four-hour dialysis session, blood flow rate 300-400 ml/min 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Hemodialysis
Keywords
Hemodialysis, Nocturnal dialysis, Cardiovascular disease, Quality of Life, left ventricular hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Four-hour dialysis session, blood flow rate 300-400 ml/min
Arm Title
2
Arm Type
Active Comparator
Arm Description
Eight-hours dialysis session, blood flow rate 200-250 ml/min
Intervention Type
Procedure
Intervention Name(s)
4-hour thrice weekly in center hemodialysis
Intervention Description
conventional hemodialysis
Intervention Type
Procedure
Intervention Name(s)
8-hour thrice weekly in center hemodialysis
Intervention Description
long dialysis
Primary Outcome Measure Information:
Title
total mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
cardiovascular mortality
Time Frame
one year
Title
changes in health-related quality of life, depression burden, cognitive function
Time Frame
one year
Title
required medications
Time Frame
one year
Title
total cost
Time Frame
one year
Title
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
Title
hospitalization rate
Time Frame
one year
Title
Vascular access patency
Time Frame
one year
Title
post-dialysis body weight and total body water
Time Frame
one year
Title
arrythmia episodes determined by Holter-ECG
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Ok, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FMC Turkey Clinics
City
Adana
ZIP/Postal Code
01100
Country
Turkey
Facility Name
Ege University School of Medicine Nephrology Department
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22172590
Citation
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.
Results Reference
derived

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

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