Evidence map›Paper›PMID 38837803›Full record

ArticleJPEN. Journal of parenteral and enteral nutrition2024

Administration of 4% tetrasodium EDTA lock solution and central venous catheter complications in high-risk pediatric patients with intestinal failure: A retrospective cohort study.

Thomas I Hirsch, Scott C Fligor, Savas T Tsikis, Paul D Mitchell, Angela DeVietro, Sarah Carbeau, Sarah Z Wang, Jennifer McClelland, Alexandra N Carey, Kathleen M Gura and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in JPEN. Journal of parenteral and enteral nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04559334 (Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04559334 nasuspendednot on this map

Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients

TypeinterventionalSponsorBoston Children's HospitalRan2020 to 2027Enrolled15ConditionsCentral Line Complication, Central Line-associated Bloodstream Infection (CLABSI)ArmsTetrasodium EDTA Catheter Lock Solution
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Updates in Intestinal Failure Management.Journal of clinical medicine · 2025
    Review
  4. Review
  5. Article
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

11 authors.

Thomas I HirschVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-1373-2388
Scott C FligorVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0003-4591-9371
Savas T TsikisVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0001-7588-8372
Paul D MitchellBiostatistics and Research Design Center, Boston Children's Hospital, Boston, Massachusetts, USA.
Angela DeVietroVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0009-0000-3785-5203
Sarah CarbeauVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-0658-9835
Sarah Z WangVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0003-3080-6665
Jennifer McClellandDivision of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.
Alexandra N CareyHarvard Medical School, Boston, Massachusetts, USA.
Kathleen M GuraHarvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-0431-896X
Mark PuderVascular Biology Program, Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-7941-2926

Funding

HARVARD-LONGWOOD RESEARCH TRAINING IN VASCULAR SURGERYT32HL007734 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI FERRAN, CHRISTIANE, LOGERFO, FRANK W · 1993 to 2023
$10.5M
RESEARCH TRAINING IN ALIMENTARY TRACT SURGERYT32DK007754 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI HODIN, RICHARD A. · 1997 to 2025
$6.5M
Novel Therapeutic Approaches for the Management of Diebetic Foot UlcerationR24DK091210 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI LOGERFO, FRANK W, MOONEY, DAVID J · 2012 to 2012
$524k
NHLBI NIH HHS T32 HL007734NIDDK NIH HHS R24 DK091210NIDDK NIH HHS T32 DK007754This project was supported by National Institutes of Health 5T32HL007734 (Scott C. Fligor and Thomas I. Hirsch) and 2T32DK007754-22 (Savas T. Tsikis), the Richard and Sandra Cummings Research Fellowship of the Beth Israel Deaconess Medical Center Department of Surgery (Scott C. Fligor), Boston Children's Hospital Vascular Biology Program, Boston Children's Hospital Surgical Foundation, Hannah Lillie Fund; Maisie Ellis & Friends Fund, and Luke Raymond Celaya Research Fund. SterileCare (Markam, Ontario, Canada) provided financial support for statistical analysis and the 4% tetrasodium EDTA at no charge
6 · The paper itself

Abstract

backgroundSelection of central venous catheter (CVC) lock solution impacts catheter mechanical complications and central line-associated bloodstream infections (CLABSIs) in pediatric patients with intestinal failure. Disadvantages of the current clinical standards, heparin and ethanol lock therapy (ELT), led to the discovery of new lock solutions. High-risk pediatric patients with intestinal failure who lost access to ELT during a recent shortage were offered enrollment in a compassionate use trial with 4% tetrasodium EDTA (T-EDTA), a lock solution with antimicrobial, antibiofilm, and antithrombotic properties.

methodsWe performed a descriptive cohort study including 14 high-risk pediatric patients with intestinal failure receiving 4% T-EDTA as a daily catheter lock solution. CVC complications were documented (repairs, occlusions, replacements, and CLABSIs). Complication rates on 4% T-EDTA were compared with baseline rates, during which patients were receiving either heparin or ELT (designated as heparin/ELT).

resultsPatients initiated 4% T-EDTA at the time they were enrolled in the compassionate use protocol. Use of 4% T-EDTA resulted in a 50% reduction in CVC complications, compared with baseline rates on heparin/ELT (incidence rate ratio: 0.50; 95% CI, 0.25-1.004; P = 0.051).

conclusionIn a compassionate use protocol for high-risk pediatric patients with intestinal failure, the use of 4% T-EDTA reduced composite catheter complications, including those leading to emergency department visits, hospital admissions, additional procedures, and mortality. This outcome suggests 4% T-EDTA has benefits over currently available lock solutions.

Indexed as

Catheterization, Central VenousCatheter-Related InfectionsCentral Venous CathetersEdetic AcidIntestinal FailureChildChild, PreschoolCohort StudiesCompassionate Use TrialsFemaleHeparinHumansInfantMaleRetrospective StudiesEdetic AcidHeparin4% tetrasodium EDTAbacteremiaethanol/adverse effectsintestinal failurepediatrics

Identifiers

PMID38837803
PMCPMC11216891

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.