Heart failure & cardiomyopathiesRandomised controlled trial
Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors
- Randomised controlled trial
- open-label
- placebo-controlled
- multicentre (15 US organ-procurement organizations)
Authors' conclusion
In hemodynamically unstable brain-dead potential heart donors, intravenous levothyroxine infusion did not result in significantly more hearts being transplanted than saline infusion.
Study context
- Population
- Hemodynamically unstable potential heart donors within 24 hours after declaration of death by neurologic criteria838 in primary analysis
- Participants
- 852 donors
- Comparison
- IV levothyroxine vs saline placebo
- Levothyroxinen = 419
- Salinen = 419reference
- Primary endpoint
- Transplantation of the donor heart
Primary result
Heart transplanted
Adjusted relative risk
1.01
95% CI 0.97–1.07
P = 0.57
Events by treatment group
Levothyroxine vs Saline
adjusted RR 1.01 (95% CI 0.97–1.07); P = 0.57
As reported in the abstract
Secondary outcomes
| Outcome | Levothyroxine | Saline | difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Graft survival (prespecified recipient safety outcome) · 30 days after transplantation | 97.4% | 95.5% | 1.9 (−2.3 to 6.0) | P for non-inferiority < 0.001 | |
| −50510Difference, percentage points (linear scale) |
- Graft survival (prespecified recipient safety outcome): non-inferiority margin 6 percentage points; noninferior
Weaning from vasopressors, echocardiographic EF, organs transplanted per donor
- No substantial between-group differences
Safety
Severe hypertension and tachycardia
- More cases with levothyroxine than saline
Original publication
Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors. N Engl J Med. Published 30 November 2023. doi:10.1056/nejmoa2305969
Summarised from the published abstract; every number is checked against it