The Effects of Frequent Nocturnal Home Hemodialysis
The Effects of Frequent Nocturnal Home Hemodialysis
Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V urea, a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.
Patients on maintenance hemodialysis in the United States have suffered from annual mortality rates of ~18–20% for two decades. The National Cooperative Dialysis Study demonstrated that an insufficient dialysis dose was associated with a higher hospitalization rate. However, the HEMO study indicated that an increased dose of dialysis provided during the three times per week hemodialysis did not significantly improve survival, cardiovascular, or infection-related hospitalizations or improve health-related quality of life, functional status, or nutritional status.
Investigators have hypothesized that an increased frequency of hemodialysis could lead to improved patient outcomes, as increased frequency results in both an increased clearance of solutes and a reduced interdialytic change in volume. More frequent dialysis can be performed through either a short daily schedule or a longer overnight or nocturnal schedule. Observational studies of nocturnal hemodialysis performed 5 to 6 nights per week and one randomized trial published after we started have suggested that frequent nocturnal hemodialysis was associated with decreased left ventricular (LV) mass, improved control of hypertension, a marked increase in phosphorus clearance, often leading to the discontinuation of phosphate binders, and, in some studies, with improved nutritional status, health-related quality of life, and sleep apnea. The Frequent Hemodialysis Network (FHN) Nocturnal Trial was designed to rigorously compare frequent nocturnal home hemodialysis six times per week with conventional three times per week hemodialysis using a randomized controlled clinical trial design.
Abstract and Introduction
Abstract
Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V urea, a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.
Introduction
Patients on maintenance hemodialysis in the United States have suffered from annual mortality rates of ~18–20% for two decades. The National Cooperative Dialysis Study demonstrated that an insufficient dialysis dose was associated with a higher hospitalization rate. However, the HEMO study indicated that an increased dose of dialysis provided during the three times per week hemodialysis did not significantly improve survival, cardiovascular, or infection-related hospitalizations or improve health-related quality of life, functional status, or nutritional status.
Investigators have hypothesized that an increased frequency of hemodialysis could lead to improved patient outcomes, as increased frequency results in both an increased clearance of solutes and a reduced interdialytic change in volume. More frequent dialysis can be performed through either a short daily schedule or a longer overnight or nocturnal schedule. Observational studies of nocturnal hemodialysis performed 5 to 6 nights per week and one randomized trial published after we started have suggested that frequent nocturnal hemodialysis was associated with decreased left ventricular (LV) mass, improved control of hypertension, a marked increase in phosphorus clearance, often leading to the discontinuation of phosphate binders, and, in some studies, with improved nutritional status, health-related quality of life, and sleep apnea. The Frequent Hemodialysis Network (FHN) Nocturnal Trial was designed to rigorously compare frequent nocturnal home hemodialysis six times per week with conventional three times per week hemodialysis using a randomized controlled clinical trial design.