PHILADELPHIA – Extended time on hemodialysis each week produced some modest improvement in lab values but didn’t result in any overall increases in quality of life for patients.
A dialysis regimen of at least 24 hours weekly failed to confer any significant benefits on blood pressure, weight, or 12-month cardiovascular outcomes, Dr. Meg Jardine said at Kidney Week 2014, which was sponsored by the American Society of Nephrology.
A follow-up period of 12 months, however, probably isn’t long enough to detect any potential cardiovascular benefits, noted Dr. Jardine of the George Institute of Global Health of Sydney.
The ACTIVE Dialysis Multinational Trial was conducted at 40 centers in Australia, China, New Zealand, and the U.K. It randomized 200 patients with end-stage renal disease to either standard dialysis (12-18 hours weekly) or the extended regimen (24-28 hours). Dialysis could be carried out at home or in a center. The primary endpoint was any change in health-related quality of life as measured on the EQ-5D, an internationally validated health quality of life measure, which was administered every 3 months. The EQ-5D score ranges from 0-1, with 0 being death and 1 being perfect health.
Secondary outcomes included overall survival, changes in biochemical and hematological markers, and safety including vascular access issues. A prespecified subanalysis examined changes in left ventricular mass index.
Patients were a mean of 52 years old. Most (70%) were male. At baseline, they received dialysis for a mean of 14 hours per week; 88% of dialysis was performed at a dialysis center. Access was via a native arteriovenous fistula in 84% of patients. The baseline EQ-5D score was 0.76 in the standard-dialysis group and 0.79 in the extended-dialysis group.
After 12 months, neither of the groups experienced any significant improvements in overall quality of life measures, Dr. Jardine said. There was a nonsignificant indication that the physical health subscale improved among patients who had the extended dialysis. There was no change in the mental health subscale in either group.
Patients in the extended-dialysis group did experience some significant improvements in laboratory measures. Potassium and phosphate levels declined significantly from baseline – enough to eliminate the need for a phosphate binder for many, she said. Calcium increased significantly, as did hemoglobin.
Both diastolic and systolic blood pressure improved somewhat, and although those improvements were not statistically significant, they did confer a significant decrease in the need for antihypertensive therapy.
At the 12-month follow up, imaging revealed that patients in the extended-dialysis group had a greater left ventricular mass – a mean of 2.84 g/m2 more than that seen in the standard-dialysis group. The short follow-up time, however, makes interpretation of this finding difficult, Dr. Jardine said.
There were no significant differences in serious adverse effects between the groups. There were two deaths and three transplants in the standard arm, compared with five deaths and two transplants in the extended dialysis arm – not a significant difference.
Dr. Jardine disclosed that she has received honoraria from Servier Laboratories and Amgen.