Frequent Hemodialysis Network Nocturnal Trial

Purpose: 
To determine if nocturnal hemodialysis results in clinically significant improvements in physiological, health-related quality of life (HRQL) and functional outcomes, as compared with in-center conventional HD. 

Design: 
Randomized, unblinded multi-center study of six times per week nocturnal home hemodialysis versus three times per week in-center hemodialysis. All patients will be assessed for suitability for nocturnal home hemodialysis using a standardized method prior to patients entering the baseline portion of this protocol. Since the intervention is unblinded, significant efforts will be made to reduce bias. These include: standardization of interventions, blinding interviewers, blinding the assessment of subjective outcomes, in addition to collecting objective outcomes. Patients will be treated and followed for fourteen months

Outcome:
The primary outcomes are a composite of mortality with left ventricular mass index measured by cardiac MRI, and a composite of mortality with the SF-36 RAND physical health composite score. The secondary outcomes are the change in Left Ventricular Mass Index by cine-MRI, the change in SF-36 RAND physical health composite score , the change in Beck Depression Inventory Score, the change in Trailmaking Test B score, the change in serum albumin concentration, the change in pre-dialysis serum phosphorus concentration, and the rate of non-access hospitalization or death.

Sample size: 
For the entire study: 250 patients. U of Iowa: 20; 5 in the first year

Duration:
5 ½ years (for the five phases) 

Start Date: 
December 2003 (enrollment begins January 2006)

Stop Date:
April 2009 (follow-up will end on January 31, 2009)

Investigators:  
John Stokes, M.D., Douglas Somers, M.D.

Coordinators:   
Kathy Lilli, R.N., Allison Hilkin

Funding:
NIH