2023-11-29 ワシントン大学セントルイス校
◆これは臓器提供の品質管理において定着していたが、実際には効果がないことが明らかになり、その使用は中止されるべきとの結論が出たものです。
◆過去の観察研究では、死亡者に甲状腺ホルモンを与えることが心臓の有効性を高める可能性が示唆されていましたが、この臨床試験によりその効果が確認できなかったとされています。
<関連情報>
- https://source.wustl.edu/2023/11/long-standing-hormone-treatment-for-donated-hearts-found-to-be-ineffective/
- https://medicine.wustl.edu/news/long-standing-hormone-treatment-for-donated-hearts-found-to-be-ineffective/
- https://www.nejm.org/doi/10.1056/NEJMoa2305969
不安定な脳死心臓ドナーへのレボチロキシン静注 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,and Daniel J. Lebovitz
The New England Journal of Medicine Published:November 30, 2023
DOI: 10.1056/NEJMoa2305969
Abstract
BACKGROUND
Hemodynamic 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.
METHODS
In 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.
RESULTS
Of 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.
CONCLUSIONS
In 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. opens in new tab.)
