Evidence map›Paper›PMID 38048188›Full record

Trial reportThe New England journal of medicine2023

Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors.

Rajat Dhar, Gary F Marklin, W Dean Klinkenberg, Jinli Wang, Charles W Goss, Abhijit V Lele, Clark D Kensinger, Paul A Lange, Daniel J Lebovitz

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

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04415658 (A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
11.3field-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.

NCT04415658 phase3completednot on this map

A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors

TypeinterventionalSponsorWashington University School of MedicineRan2020 to 2022Enrolled838ConditionsBrain Death, Heart FailureArmsThyroxine, Saline
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Heart donation and transplant recipient survival outcomes from deceased organ donors managed in hospital-based vs independent donor care units.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2025
    Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Year in Review 2023: Noteworthy Literature in Cardiac Anesthesiology.Seminars in cardiothoracic and vascular anesthesia · 2024
    Review
  13. Article
  14. Article
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Rajat DharFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).ORCID 0000-0002-5167-5097
Gary F MarklinFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
W Dean KlinkenbergFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Jinli WangFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Charles W GossFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Abhijit V LeleFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).ORCID 0000-0002-6956-538X
Clark D KensingerFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Paul A LangeFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Daniel J LebovitzFrom the Department of Neurology, Section of Neurocritical Care (R.D.), and the Center for Biostatistics and Data Science (J.W., C.W.G.), Washington University School of Medicine, and Mid-America Transplant (G.F.M., W.D.K.) - both in St. Louis; the Department of Anesthesiology and Pain Medicine, University of Washington, Harborview Medical Center, Seattle, and LifeCenter Northwest, Bellevue - both in Washington (A.V.L.); LifeLink of Georgia, Norcross, and Piedmont Transplant Institute, Atlanta - both in Georgia (C.D.K.); Donor Alliance, Denver (P.A.L.); and Akron Children's Hospital, Akron, OH (D.J.L.).
Harborview Medical Center · USUniversity of Washington · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI AIMEE S JAMES · 2001 to 2026
$128.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Genetic Architecture of Cerebral Edema after StrokeR01NS121218 · NINDS · WASHINGTON UNIVERSITY · PI Rajat Raj Dhar · 2022 to 2026
$1.9M
NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1TR002345NCI NIH HHS P30 CA091842NINDS NIH HHS R01 NS121218
6 · The paper itself

Abstract

backgroundHemodynamic instability and myocardial dysfunction are major factors preventing the transplantation of hearts from organ donors after brain death. Intravenous levothyroxine is widely used in donor care, on the basis of observational data suggesting that more organs may be transplanted from donors who receive hormonal supplementation.

methodsIn this trial involving 15 organ-procurement organizations in the United States, we randomly assigned hemodynamically unstable potential heart donors within 24 hours after declaration of death according to neurologic criteria to open-label infusion of intravenous levothyroxine (30 μg per hour for a minimum of 12 hours) or saline placebo. The primary outcome was transplantation of the donor heart; graft survival at 30 days after transplantation was a prespecified recipient safety outcome. Secondary outcomes included weaning from vasopressor therapy, donor ejection fraction, and number of organs transplanted per donor.

resultsOf the 852 brain-dead donors who underwent randomization, 838 were included in the primary analysis: 419 in the levothyroxine group and 419 in the saline group. Hearts were transplanted from 230 donors (54.9%) in the levothyroxine group and 223 (53.2%) in the saline group (adjusted risk ratio, 1.01; 95% confidence interval [CI], 0.97 to 1.07; P = 0.57). Graft survival at 30 days occurred in 224 hearts (97.4%) transplanted from donors assigned to receive levothyroxine and 213 hearts (95.5%) transplanted from donors assigned to receive saline (difference, 1.9 percentage points; 95% CI, -2.3 to 6.0; P<0.001 for noninferiority at a margin of 6 percentage points). There were no substantial between-group differences in weaning from vasopressor therapy, ejection fraction on echocardiography, or organs transplanted per donor, but more cases of severe hypertension and tachycardia occurred in the levothyroxine group than in the saline group.

conclusionsIn hemodynamically unstable brain-dead potential heart donors, intravenous levothyroxine infusion did not result in significantly more hearts being transplanted than saline infusion. (Funded by Mid-America Transplant and others; ClinicalTrials.gov number, NCT04415658.).

Indexed as

Brain DeathHeart TransplantationThyroxineTissue and Organ ProcurementTissue DonorsAdministration, IntravenousBrainHemodynamicsHumansThyroxine

Identifiers

PMID38048188
PMCPMC10752368
OpenAlexW4389120364

What OpenQuestion holds

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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.