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

Ege University

Status and phase: Completed; Phase 4

Conditions: End-Stage Renal Disease; Hemodialysis

Treatments: Procedure: 8-hour thrice weekly in center hemodialysis; Procedure: 4-hour thrice weekly in center hemodialysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00413803

06-5.1/8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

1

Other group

Description:

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

Treatment:

Procedure: 4-hour thrice weekly in center hemodialysis

2

Active Comparator group

Description:

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

Treatment:

Procedure: 8-hour thrice weekly in center hemodialysis