Hemodialysis Clinical Trial
Official title:
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
Verified date | August 2009 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 410 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | FMC Turkey Clinics | Adana | |
Turkey | Ege University School of Medicine Nephrology Department | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University | Fresenius Medical Care North America |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total mortality | one year | ||
Secondary | cardiovascular mortality | one year | ||
Secondary | changes in health-related quality of life, depression burden, cognitive function | one year | ||
Secondary | required medications | one year | ||
Secondary | total cost | one year | ||
Secondary | 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 ß-2 microglobulin | one year | ||
Secondary | hospitalization rate | one year | ||
Secondary | Vascular access patency | one year | ||
Secondary | post-dialysis body weight and total body water | one year | ||
Secondary | arrythmia episodes determined by Holter-ECG | one year |
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