End-Stage Renal Disease, Hemodialysis
Conditions
Keywords
Hemodialysis, Nocturnal dialysis, Cardiovascular disease, Quality of Life, left ventricular hypertrophy
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: 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.
Interventions
PROCEDURE4-hour thrice weekly in center hemodialysis
conventional hemodialysis
PROCEDURE8-hour thrice weekly in center hemodialysis
long dialysis
Sponsors
Fresenius Medical Care North America
Ege University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total mortality | one year |
Secondary
| Measure | Time frame |
|---|---|
| changes in health-related quality of life, depression burden, cognitive function | one year |
| required medications | one year |
| total cost | one year |
| 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 | one year |
| cardiovascular mortality | one year |
| Vascular access patency | one year |
| post-dialysis body weight and total body water | one year |
| arrythmia episodes determined by Holter-ECG | one year |
| hospitalization rate | one year |
Countries
Turkey (Türkiye)
Outcome results
None listed