Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors

This multicenter randomized controlled trial (NCT04415658) evaluated intravenous levothyroxine (30 µg/hr for ≥12 hr) versus saline placebo in 852 brain-dead, hemodynamically unstable potential heart donors. Conducted across 15 U.S. organ procurement organizations (OPOs), the primary outcome was heart transplantation; safety was measured by 30-day graft survival. Among 838 evaluable donors (419/group), hearts were transplanted from 230 (54.9%) in the levothyroxine group vs. 223 (53.2%) in the saline group (adjusted RR: 1.01; 95% CI: 0.97–1.07; P=0.57). Graft survival was 97.4% vs. 95.5%, meeting noninferiority criteria. Secondary outcomes (vasopressor weaning, ejection fraction, organ yield) showed no significant differences, though levothyroxine caused more adverse events (severe hypertension, tachycardia). Free T4 rose ~37% post-infusion. Subgroup analyses (LVEF, free T4 levels, vasopressor-inotrope score) showed consistent null results. The study concluded that levothyroxine does not improve donor cardiovascular stability or heart utilization rates and may introduce unnecessary risks, challenging its routine use in donor protocols.

This multicenter randomized controlled trial (NCT04415658) evaluated intravenous levothyroxine (30 µg/hr for ≥12 hr) versus saline placebo in 852 brain-dead, hemodynamically unstable potential heart donors. Conducted across 15 U.S. organ procurement organizations (OPOs), the primary outcome was heart transplantation; safety was measured by 30-day graft survival. Among 838 evaluable donors (419/group), hearts were transplanted from 230 (54.9%) in the levothyroxine group vs. 223 (53.2%) in the saline group (adjusted RR: 1.01; 95% CI: 0.97–1.07; P=0.57). Graft survival was 97.4% vs. 95.5%, meeting noninferiority criteria. Secondary outcomes (vasopressor weaning, ejection fraction, organ yield) showed no significant differences, though levothyroxine caused more adverse events (severe hypertension, tachycardia). Free T4 rose ~37% post-infusion. Subgroup analyses (LVEF, free T4 levels, vasopressor-inotrope score) showed consistent null results. The study concluded that levothyroxine does not improve donor cardiovascular stability or heart utilization rates and may introduce unnecessary risks, challenging its routine use in donor protocols.