Evidence map›Paper›PMID 25863828›Full record

Trial reportAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2015

Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial.

Michael V Rocco, John T Daugirdas, Tom Greene, Robert S Lockridge, Christopher Chan, Andreas Pierratos, Robert Lindsay, Brett Larive, Glenn M Chertow, Gerald J Beck and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03239808 (Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
11.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03239808 naactive not recruitingnot on this mapstarted 2018, after this paper: background citation

Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients

TypeinterventionalSponsorFundación para la Formación e Investigación de los Profesionales de la Salud de ExtremaduraRan2018 to 2025Enrolled152ConditionsRenal Disease, End-StageArmsIncremental haemodialysis, Conventional haemodialysis
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Guideline
  3. Trial
  4. A Randomized, Single-Blind, Crossover Trial of Recovery Time in High-Flux Hemodialysis and Hemodiafiltration.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2017
    Trial
  5. A Trial of Extending Hemodialysis Hours and Quality of Life.Journal of the American Society of Nephrology : JASN · 2017
    Trial
  6. Trial
  7. The Role of Analysis Populations and Estimands in Clinical Trials.Journal of the American Society of Nephrology : JASN · 2026
    Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 2 countries.

Michael V RoccoDepartment of Medicine, Wake Forest University, Winston-Salem, NC. Electronic address: mrocco@wakehealth.edu.
John T DaugirdasDepartment of Medicine, University of Illinois at Chicago, Chicago IL.
Tom GreeneDepartment of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.
Robert S LockridgeLynchburg Nephrology Physicians, University of Virginia, Lynchburg, VA.
Christopher ChanUniversity Health Network, University of Toronto, Toronto, Ontario, Canada.
Andreas PierratosHumber River Hospital, University of Toronto, Toronto, Ontario, Canada.
Robert LindsayLondon Health Sciences Center, London, Ontario, Canada.
Brett LariveDepartment of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH.
Glenn M ChertowStanford University School of Medicine, Stanford, CA.
Gerald J BeckDepartment of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH.
Paul W EggersNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Alan S KligerYale New Haven Hospital and Yale School of Medicine, New Haven, CT.
FHN Trial Group
Cleveland Clinic · USHumber River Regional Hospital · CALondon Health Sciences Centre · CANational Institute of Diabetes and Digestive and Kidney Diseases · USStanford University · USUniversity of Illinois Chicago · USUniversity of Lynchburg · USUniversity of Toronto · CAUniversity of Utah · USWake Forest University · USYale New Haven Hospital · US

Funding

Frequent Hemodialysis Network (FHN) - Nocturnal Clinical Core ConsortiumU01DK066480 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ROCCO, MICHAEL V · 2003 to 2010
$3.7M
NIDDK NIH HHS U01 DK066480
6 · The paper itself

Abstract

backgroundFew data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis. STUDY

designPosttrial observational study. SETTING &

participantsFrequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up.

interventionThe FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year. Patients were enrolled starting in March 2006 and follow-up was completed by May 2010. After the 1-year trial concluded, FHN Nocturnal participants were free to modify their hemodialysis prescription. OUTCOMES & MEASUREMENTS: We obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers. We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment.

resultsMedian follow-up for the trial and posttrial observational period was 3.7 years. In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively. In the nocturnal dialysis group, the overall mortality HR was 3.88 (95% CI, 1.27-11.79; P=0.01). Using as-treated analysis with a 12-month running treatment average, the HR for mortality was 3.06 (95% CI, 1.11-8.43; P=0.03). Six-month running treatment data analysis showed an HR of 1.12 (95% CI, 0.44-3.22; P=0.7). LIMITATIONS: These results should be interpreted cautiously due to a surprisingly low (0.03 deaths/patient-year) mortality rate for individuals randomly assigned to conventional home hemodialysis, low statistical power for the mortality comparison due to the small sample size, and the high rate of hemodialysis prescription changes.

conclusionsPatients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis. The implications of this result require further investigation.

Indexed as

Hemodialysis, HomeKidney Failure, ChronicAdolescentAdultCause of DeathFemaleHumansIntention to Treat AnalysisMaleMiddle AgedYoung Adultclinical trialdialysis adequacydialysis dosedialysis regimenend-stage renal disease (ESRD)extended hemodialysisfrequent hemodialysisFrequent Hemodialysis Network (FHN) Nocturnal Trialfrequent-long dialysis schedulehemodialysis prescriptionmortalityNocturnal hemodialysisrenal replacement therapy

Identifiers

PMID25863828
PMCPMC4549208
OpenAlexW2159713749

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.