Wake Forest University has established a clinical consortium to provide six times per week nocturnal home hemodialysis for the NIH RFA for Frequent Hemodialysis Clinical Trials. This consortium consists of ten clinical sites located in the eastern United States, eastern Canada and the Midwestern United States. The consortium includes four of the largest nocturnal home hemodialysis programs in the United States, located in Lynchburg, VA, Saratoga Springs, NY, New York City, NY and Kansas City, MO and one of the largest nocturnal home hemodialysis programs in Canada at London, Ontario. Our clinical centers have more than 190 patient-years of experience with nocturnal home hemodialysis and have provided more than 60,000 home nocturnal hemodialysis treatments. The one year mortality rate for patients receiving nocturnal home hemodialysis at these centers is 4.7% (based on 84.9 patient-years of follow-up), significantly less than the 16.6% mortality rate observed in the NIH sponsored HEMO Study. The observed one year mortality rate for this cohort was 4, compared to an expected mortality rate of 15.8 (chi-square = 8.8, p < 0.005). This consortium proposes to randomize chronic end stage renal disease patients to either six times per week nocturnal home hemodialysis or standard three times per week hemodialysis. Patients will be assessed for the suitability of nocturnal home hemodialysis via a standardized protocol during the baseline period. Those patients that are found to be suitable will then be randomized. Patients will be followed for 12 to 18 months. The primary goals of this study will be to determine the feasibility of randomizing patients into this trial. The primary outcome for the study will be all-cause hospitalizations. Secondary outcomes will include mortality, protein and energy intake, anthropometrics, quality of life, functional status and physical activity. Laboratory data, dialysis parameters and patient medications will also be collected to assess the impact of the interventions on hypertension, anemia, and secondary hyperparathyroidism and electrolyte abnormalities. All hospitalizations, including inpatient and outpatient access interventions, will also be tracked. Direct cost estimates of the two different hemodialysis treatments from a limited societal perspective will also be obtained. Patient safety will be monitored by an external Data Safety and Monitoring Board.
