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Citation
Beck, Gerald (2016). Frequent Hemodialysis Network Daily Trial (FHN Daily) (Version 4) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/bx72-p494
Data Availability Statement
Data from the Frequent Hemodialysis Network Daily Trial (FHN Daily) [(Version 4) https://doi.org/10.58020/bx72-p494] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The FHN Daily study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the FHN Daily (https://doi.org/10.58020/bx72-p494) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the FHN Daily study and does not necessarily reflect the opinions or views of the FHN Daily study, NIDDK-CR, or NIDDK.
Data Package Version
Version 4 (Updated on: Aug 15, 2016)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
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General Description

The FHN Daily Trial was a randomized controlled trial which recruited subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects were randomized to either conventional hemodialysis delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week (120 patients), or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week (125 patients). The study had 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.

Note: The available data do not contain digital raw ECG recordings. Please review the Data Dictionary for a listing of available datasets and variables.

Objectives

To assess if more frequent hemodialysis resulted in better outcomes at 12 months.

Outcome Measure

The two coprimary composite outcomes were death or change (from baseline to 12 months) in left ventricular mass, as assessed by cardiac magnetic resonance imaging, and death or change in the physical-health composite score of the RAND 36-item health survey. Secondary outcomes included cognitive performance; self-reported depression; laboratory markers of nutrition, mineral metabolism, and anemia; blood pressure; and rates of hospitalization and of interventions related to vascular access.

Eligibility Criteria

End stage renal disease requiring chronic dialysis

Outcome

Patients in the frequent-hemodialysis group averaged 5.2 sessions per week; the weekly standard Kt/V(urea) (the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group (3.54±0.56 vs. 2.49±0.27). Frequent hemodialysis was associated with significant benefits with respect to both coprimary composite outcomes (hazard ratio for death or increase in left ventricular mass, 0.61; 95% confidence interval [CI], 0.46 to 0.82; hazard ratio for death or a decrease in the physical-health composite score, 0.70; 95% CI, 0.53 to 0.92). Patients randomly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis (hazard ratio, 1.71; 95% CI, 1.08 to 2.73). Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia. There were no significant effects of frequent hemodialysis on cognitive performance, self-reported depression, serum albumin concentration, or use of erythropoiesis-stimulating agents.

Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access.

Research Area

Kidney Disease

Study Type

Interventional

Study Sites

2

Study Start Date

2006-01

Study End Date

2010-03

Condition

End Stage Renal Failure

Keywords

Randomized Controlled Trial, Renal Insufficiency, Left Ventricular Mass, End Stage Renal Disease (ESRD), Frequent Hemodialysis, Magnetic Resonance Imaging (MRI), SF-36 RAND Physical Health Composite (PHC), Conventional Hemodialysis, Comparative Effectiveness Research

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

378
Participants

Target Population
Dialysis Patients, Adults, Children
Location statistics is not available for this study

Public Documents Table
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Compliance
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Datasets (99)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Specimens (47,414)
Specimens Table
Specimen
Count
Plasma24204
Serum23210