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

Phase 4

Completed

• Conditions: End-Stage Renal Disease; Hemodialysis
• Interventions: Procedure: 4-hour thrice weekly in center hemodialysis; Procedure: 8-hour thrice weekly in center hemodialysis

• Registration Number: NCT00413803
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	4-hour thrice weekly in center hemodialysis	Four-hour dialysis session, blood flow rate 300-400 ml/min
2	8-hour thrice weekly in center hemodialysis	Eight-hours dialysis session, blood flow rate 200-250 ml/min

Primary Outcome Measures

Name	Time	Method
total mortality	one year

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	one year
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
hospitalization rate	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

Trial Locations

Locations (2)

FMC Turkey Clinics; 🇹🇷 Adana, Turkey

Ege University School of Medicine Nephrology Department; 🇹🇷 Izmir, Turkey