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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413803
• Other study ID #: 06-5.1/8
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2006
• Last updated: August 3, 2009
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2009
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• 4-hour thrice weekly in center hemodialysis
conventional hemodialysis
• 8-hour thrice weekly in center hemodialysis
long dialysis

Locations

Country	Name	City	State
Turkey	FMC Turkey Clinics	Adana
Turkey	Ege University School of Medicine Nephrology Department	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Fresenius Medical Care North America

Country where clinical trial is conducted

Turkey, 

Outcome

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