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https://repository.niddk.nih.gov/study/44
Randomized controlled clinical trial to understand how increasing hemodialysis to six times a week from the standard of three times a week may result in improved heart health. Subjects were recruited from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialyis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes.
Proper citation: Frequent Hemodialysis Network Daily Trial (RRID:SCR_001527) Copy
http://clinicaltrials.gov/show/NCT00271999
Randomized controlled clinical trial where subjects will be randomized to conventional hemodialysis delivered three days per week home arm or to the six times per week nocturnal home hemodialysis arm which will follow any dialysis prescription provided their prescribed standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per week. Subjects were recruited from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 12 months. Primary Outcome Measures: * composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, * a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite Secondary Outcome Measures: * cardiovascular structure/funct (change in LV mass over 12 mos), health-related QoL/phys funct (change over 12 mos in PHC), * depression / dis burden (change over 12 mos in Beck Depression Inv.), nutrition (change over 12 mos in serum albumin, cognitive funct (change over 12 mos in TrailMaking Test B), mineral metabolism (change over 12 mos in aveg pre-dialysis serum phosphorus), * clin events (rate of non-access hospital or death * hypertension, anemia
Proper citation: Frequent Hemodialysis Network Nocturnal Trial (RRID:SCR_007014) Copy
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