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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; End-Stage Renal Disease
• Intervention / Treatment: Procedure: 4-hour thrice weekly in center hemodialysis; Procedure: 8-hour thrice weekly in center hemodialysis

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 Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01100
    • FMC Turkey Clinics
  • Izmir, Turkey, 35100
    • Ege University School of Medicine Nephrology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Four-hour dialysis session, blood flow rate 300-400 ml/min	Procedure: 4-hour thrice weekly in center hemodialysis; conventional hemodialysis
Active Comparator: 2; Eight-hours dialysis session, blood flow rate 200-250 ml/min	Procedure: 8-hour thrice weekly in center hemodialysis; long dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total mortality	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ege University
• Collaborators: Fresenius Medical Care North America
• Investigators: Principal Investigator: Ercan Ok, MD, Ege University

Publications and helpful links

General Publications

• Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 19, 2006
• First Submitted That Met QC Criteria: December 19, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): August 4, 2009
• Last Update Submitted That Met QC Criteria: August 3, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Quality of Life; Hemodialysis; left ventricular hypertrophy; Nocturnal dialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 06-5.1/8