Status:
COMPLETED
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
Lead Sponsor:
Ege University
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
End-Stage Renal Disease
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 requi...
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 la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00413803
Start Date
December 1 2006
End Date
February 1 2008
Last Update
August 4 2009
Active Locations (2)
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1
FMC Turkey Clinics
Adana, Turkey (Türkiye), 01100
2
Ege University School of Medicine Nephrology Department
Izmir, Turkey (Türkiye), 35100