IV Thyroxine for Heart-Eligible Organ Donors
Trial question
What is the role of IV levothyroxine in hemodynamically unstable brain-dead potential heart donors?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 838
838 patients (280 female, 558 male).
Inclusion criteria: hemodynamically unstable brain-dead potential heart donors within 24 hours after declaration of death according to neurologic criteria.
Key exclusion criteria: hearts not being considered for transplantation because of known heart disease or receipt of thyroid hormone within the past month.
Interventions
N=419 levothyroxine (IV infusion rate of 30 mcg/hr for a minimum of 12 hours).
N=419 placebo (matching volume of IV saline for a minimum of 12 hours).
Primary outcome
Transplantation of donor heart
54.9%
53.2%
54.9 %
41.2 %
27.4 %
13.7 %
0.0 %
Levothyroxine
Placebo
No significant
difference ↔
No significant difference in transplantation of donor heart (54.9% vs. 53.2%; RR 1.01, 95% CI 0.97 to 1.07).
Secondary outcomes
No significant difference in transplantation of donor lungs (38.9% vs. 35.6%; RR 1.09, 95% CI 0.91 to 1.31).
No significant difference in transplantation of donor liver (80% vs. 79.9%; RR 1, 95% CI 0.92 to 1.09).
No significant difference in weaned off vasopressors at 12 hours (35.4% vs. 39.2%; RR 0.91, 95% CI 0.79 to 1.04).
Safety outcomes
No significant differences in graft survival at 30 days, serious adverse events.
Significant differences in severe hypertension (6.2% vs. 1.2%), tachycardia (3.8% vs. 0.7%).
Conclusion
In hemodynamically unstable brain-dead potential heart donors within 24 hours after declaration of death according to neurologic criteria, levothyroxine was not superior to placebo with respect to transplantation of donor heart.
Reference
Rajat Dhar, Gary F Marklin, W Dean Klinkenberg et al. Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors. N Engl J Med. 2023 Nov 30;389(22):2029-2038.
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