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Published on: September 20, 2019
Frequent Hemodialysis Network (FHN) randomized trials: study design
R S Suri1, A X Garg, G M Chertow
1Division of Nephrology, University of Western Ontario, London, Ontario, Canada. rita.suri@lhsc.on.ca
Kidney International
|December 14, 2006
Summary
Frequent hemodialysis (HD) trials compare daily or nocturnal HD versus conventional HD to assess efficacy and safety. These trials aim to determine if more frequent dialysis improves patient outcomes and reduces mortality.
Area of Science:
- Nephrology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Observational studies suggest benefits of frequent hemodialysis (HD), but robust evidence on its efficacy and safety is lacking.
- Uncertainty exists regarding the true impact of more frequent dialysis schedules on patient health outcomes.
Purpose of the Study:
- To compare the efficacy and safety of in-center daily HD and home nocturnal HD against conventional thrice-weekly HD.
- To evaluate the impact of frequent HD on mortality, left ventricular mass index (LVMI), and physical health composite (PHC) scores.
Main Methods:
- Two multicenter randomized trials involving 250 subjects each, comparing conventional HD with daily HD (1.5-2.75h, 6 days/week) and nocturnal HD (≥6h, 6 nights/week).
- Co-primary outcomes include mortality and 12-month changes in LVMI and SF-36 RAND Physical Health Composite (PHC).
- Secondary outcomes assess changes in depression, cognitive function, serum albumin and phosphorus, and hospitalization/death rates.
Main Results:
- The study is designed to evaluate the composite of mortality and changes in LVMI and PHC over 1 year.
- Secondary outcomes will provide comprehensive data on various health parameters and treatment burden.
- A Vanguard Phase will assess feasibility, intervention delivery, and adherence before full-scale enrollment.
Conclusions:
- The Frequent Hemodialysis Network Trials will provide critical data on the effectiveness and safety of daily and nocturnal hemodialysis.
- Findings are expected to inform clinical practice guidelines for hemodialysis prescription.
- This research addresses a significant gap in evidence regarding intensive HD regimens.
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