Evidence map›Paper›PMID 31400337›Full record

Trial reportThe Annals of thoracic surgery2019

Safety and Efficacy of Vasopressin After Fontan Completion: A Randomized Pilot Study.

Amee M Bigelow, Nancy S Ghanayem, Nathan E Thompson, John P Scott, Laura D Cassidy, Katherine J Woods, Ronald K Woods, Michael E Mitchell, Viktor Hraŝka, George M Hoffman

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Annals of thoracic surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04463394 (The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT04463394 early_phase1completednot on this mapstarted 2020, after this paper: background citation

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

TypeinterventionalSponsorStanford UniversityRan2020 to 2022Enrolled28ConditionsHypotension, Fontan PhysiologyArmsVasopressin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Review
  6. Evaluation of Hyponatremia in Infants on Vasopressin Therapy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  7. Article
  8. Article
  9. 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

10 authors at 3 institutions in 1 country.

Amee M BigelowDivision of Cardiology, Department of Pediatrics, Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: amee.bigelow@cchmc.org.
Nancy S GhanayemDivision of Critical Care, Department of Pediatrics, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Division of Critical Care, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas.
Nathan E ThompsonDivision of Critical Care, Department of Pediatrics, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
John P ScottDivision of Critical Care, Department of Pediatrics, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Division of Pediatric Anesthesia, Department of Anesthesia, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Laura D CassidyInstitute for Health and Equity, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Katherine J WoodsDivision of Critical Care, Department of Pediatrics, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Ronald K WoodsDivision of Congenital Heart Surgery, Department of Surgery, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Michael E MitchellDivision of Congenital Heart Surgery, Department of Surgery, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Viktor HraŝkaDivision of Congenital Heart Surgery, Department of Surgery, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
George M HoffmanDivision of Critical Care, Department of Pediatrics, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin; Division of Pediatric Anesthesia, Department of Anesthesia, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
Medical College of Wisconsin · USChildren's Hospital of Wisconsin · USCincinnati Children's Hospital Medical Center · US

Funding

Clinical and Translational Science AwardUL1TR001436 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI FREED, JULIE K · 2015 to 2025
$47.5M
J. NRSA Training CoreTL1TR001437 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI THOMAS, DANNY GEORGE · 2015 to 2024
$3.7M
NCATS NIH HHS TL1 TR001437NCATS NIH HHS UL1 TR001436
6 · The paper itself

Abstract

backgroundArginine vasopressin is a nonapeptide hormone with effects on intracellular water transport and arterial tone that is used in distributive shock and following cardiopulmonary bypass. We sought to evaluate the safety and efficacy of vasopressin infusion on hemodynamics and fluid balance in the early postoperative period after Fontan completion.

methodsWe conducted a randomized, double-blinded, placebo-controlled study of vasopressin infusion for 24 hours after cardiopulmonary bypass for Fontan completion. Patient characteristics, hospital outcomes, and measures of hemodynamic parameters, urine output, chest tube drainage, fluid balance, laboratory data, and plasma arginine vasopressin concentrations were collected at baseline and for 48 postoperative hours. Data were analyzed using mixed-effect regressions.

resultsTwenty patients were randomized, 10 to vasopressin and 10 to placebo. Transpulmonary gradient (6.4 ± 0.5 vs 8.3 ± 0.5 mm Hg, P = .011) and chest tube drainage (23 ± 20 vs 40 ± 20 mL/kg, P = .028) for 48 hours after surgery were significantly lower in the vasopressin arm compared to placebo. Arginine vasopressin concentrations were elevated above baseline after surgery until 4 hours post cardiac intensive care unit admission in both arms, and higher in the vasopressin arm during postoperative infusion. No differences in sodium concentration, liver function, or renal function were noted between groups.

conclusionsVasopressin infusion after Fontan completion appears safe and was associated with reduced transpulmonary gradient and chest tube drainage in the early postoperative period. A larger multiinstitutional study may show further outcome benefit.

Indexed as

Antidiuretic AgentsChild, PreschoolDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesFontan ProcedureHeart Defects, CongenitalHumansIncidenceInfusions, IntravenousMalePilot ProjectsPostoperative CarePostoperative ComplicationsProspective StudiesAntidiuretic AgentsVasopressins

Identifiers

PMID31400337
PMCPMC9553092
OpenAlexW2965575077

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.