Evidence map›Paper›PMID 32253271›Full record

Trial reportJournal of the American Society of Nephrology : JASN2020

Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial.

Iain C Macdougall, Sunil Bhandari, Claire White, Stefan D Anker, Kenneth Farrington, Philip A Kalra, Patrick B Mark, John J V McMurray, Chante Reid, Michele Robertson and 5 more

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
8.9field-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.

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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Article
  13. Iron Metabolism in Cardiovascular Disease.Advances in experimental medicine and biology · 2025
    Review
  14. Review
  15. Article
  16. Article
  17. Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in chronic kidney disease: a clinical practice document by the European Renal Best Practice board of the European Renal Association.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Review
  18. Article
  19. SucrosomialPharmaceuticals (Basel, Switzerland) · 2023
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 3 countries.

Iain C MacdougallDepartment of Renal Medicine, King's College Hospital, London, United Kingdom iain.macdougall11@gmail.com.
Sunil BhandariHull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull, United Kingdom.
Claire WhiteDepartment of Renal Medicine, King's College Hospital, London, United Kingdom.
Stefan D AnkerDivision of Cardiology and Metabolism, Department of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Kenneth FarringtonLister Hospital, Stevenage, United Kingdom.
Philip A KalraSalford Royal Hospital, Salford, United Kingdom.
Patrick B MarkBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.ORCID 0000-0003-3387-2123
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.ORCID 0000-0002-6317-3975
Chante ReidDepartment of Renal Medicine, King's College Hospital, London, United Kingdom.
Michele RobertsonRobertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.
Charles R V TomsonFreeman Hospital, Newcastle upon Tyne, United Kingdom.ORCID 0000-0002-0224-8726
David C WheelerUniversity College London, London, United Kingdom.
Christopher G WinearlsOxford Kidney Unit, The Churchill, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Ian FordRobertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.ORCID 0000-0001-5927-1823
PIVOTAL Investigators and Committees
King's College Hospital · GBBritish Heart Foundation · GBUniversity of Glasgow · GBBerlin-Brandenburger Centrum für Regenerative Therapien · DEChurchill Hospital · GBFreeman Hospital · GBHull York Medical School · GBSalford Royal Hospital · GBThe George Institute for Global Health · AUUniversity of Hertfordshire · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExperimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis.

methodsSecondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter).

resultsWe found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so

conclusionsThe high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.

Indexed as

AgedArteriovenous Shunt, SurgicalCardiovascular DiseasesCatheter-Related InfectionsCause of DeathCross InfectionDose-Response Relationship, DrugFemaleHospitalizationHumansInfectionsInfusions, IntravenousIronMaleMiddle AgedProportional Hazards ModelsIronchronic kidney diseasehemodialysisinfectionsintravenous ironrandomized controlled trial

Identifiers

PMID32253271
PMCPMC7217408
OpenAlexW3014325832

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.