Evidence map›Paper›PMID 31000566›Full record

Trial reportJournal of the American Society of Nephrology : JASN2019

The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.

Laura M Dember, Eduardo Lacson, Steven M Brunelli, Jesse Y Hsu, Alfred K Cheung, John T Daugirdas, Tom Greene, Csaba P Kovesdy, Dana C Miskulin, Ravi I Thadhani and 12 more

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
5.1field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Designing Pragmatic Trials to Better Inform Nephrology Practice.Journal of the American Society of Nephrology : JASN · 2026
    Article
  10. Article
  11. "Hi"s and "Lo"s of Targeting Serum Phosphate Levels in Hemodialysis.Journal of the American Society of Nephrology : JASN · 2025
    Article
  12. Article
  13. Article
  14. How to Leverage Implementation Science to Achieve Equity in Nephrology Care Delivery.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2025
    Article
  15. Article
  16. Article
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  19. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 12 institutions in 2 countries.

Laura M DemberRenal, Electrolyte and Hypertension Division, Department of Medicine, ldember@pennmedicine.upenn.edu.
Eduardo LacsonDivision of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
Steven M BrunelliDaVita Clinical Research, Minneapolis, Minnesota.
Jesse Y HsuDepartment of Biostatistics, Epidemiology, and Informatics, and.
Alfred K CheungDivision of Nephrology and Hypertension, Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, Utah.
John T DaugirdasDivision of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois.
Tom GreeneDepartments of Population Health Science and Internal Medicine, University of Utah, Salt Lake City, Utah.
Csaba P KovesdyDivision of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.ORCID 0000-0002-8204-911X
Dana C MiskulinDivision of Nephrology, Tufts Medical Center, Boston, Massachusetts.
Ravi I ThadhaniDivision of Nephrology, Massachusetts General Hospital, Boston, Massachusetts.
Wolfgang C WinkelmayerSelzman Institute for Kidney Health, Section of Nephrology, Department of Medicine, Baylor College of Medicine, Houston, Texas.
Susan S EllenbergDepartment of Biostatistics, Epidemiology, and Informatics, and.
Denise CifelliCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Rosemary MadiganCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Amy YoungDaVita Clinical Research, Minneapolis, Minnesota.
Michael AngelettiDivision of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
Rebecca L WingardDivision of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
Christina KahnDivision of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
Allen R NissensonDaVita Kidney Care, El Segundo, California.
Franklin W MadduxDivision of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
Kevin C AbbottNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.
J Richard LandisDepartment of Biostatistics, Epidemiology, and Informatics, and.
Fresenius Medical Care (United States) · USInstitute for Medical Informatics and Biostatistics · CHDaVita Clinical Research (United States) · USTufts Medical Center · USUniversity of Pennsylvania · USUniversity of Utah · USBaylor College of Medicine · USCedars-Sinai Medical Center · USIllinois College · USNational Institutes of Health · USUniversity of California, Los Angeles · USUniversity of Tennessee Health Science Center · US

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
Pragmatic Trials in Maintenance HemodialysisUH3DK102384 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2013 to 2016
$5.8M
Pragmatic Trials in Maintenance HemodialysisUH2AT007797 · NCCIH · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2012 to 2012
$851k
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS UH2 AT007797NIDDK NIH HHS UH3 DK102384
6 · The paper itself

Abstract

backgroundData from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.

methodsTo develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.

resultsThe trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.

conclusionsAlthough a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

Indexed as

Cause of DeathOutcome Assessment, Health CareAmbulatory CareCluster AnalysisFemaleHumansKidney Failure, ChronicMaleRenal DialysisSurvival RateTime FactorsUnited Statesconsent waiverdialysis session durationlearning health systemNIH Health Care Systems Research Collaboratoryopt-out consentTiME Trial

Identifiers

PMID31000566
PMCPMC6493975
OpenAlexW2940001680

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.