Clinical trial NCT00413803: Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
Official title: Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-Stage Renal Disease
Hemodialysis
Keywords: Hemodialysis
Nocturnal dialysis
Cardiovascular disease
Quality of Life
left ventricular hypertrophy
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
First posted: 2006-12-20
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: total mortality
timeFrame: one year
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: one year
measure: changes in health-related quality of life, depression burden, cognitive function
timeFrame: one year
measure: required medications
timeFrame: one year
measure: total cost
timeFrame: one year
measure: 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
timeFrame: one year
measure: hospitalization rate
timeFrame: one year
measure: Vascular access patency
timeFrame: one year
measure: post-dialysis body weight and total body water
timeFrame: one year
measure: arrythmia episodes determined by Holter-ECG
timeFrame: one year
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: FMC Turkey Clinics
city: Izmir
country: Turkey
facility: Ege University School of Medicine Nephrology Department
Study officials:
affiliation: Ege University
name: Ercan Ok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.