NCT00413803

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-Stage Renal Disease
• Hemodialysis

Interventions

Type	Name	Description
PROCEDURE	4-hour thrice weekly in center hemodialysis	conventional hemodialysis
PROCEDURE	8-hour thrice weekly in center hemodialysis	long dialysis

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-12-20
• Last updated: 2009-08-04

Locations

2 sites across 1 country: Turkey (Türkiye)