A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors
Bibliographic record
Abstract
BACKGROUND: Although commonly prescribed, the efficacy of levothyroxine to improve heart function in neurologically deceased donors is unclear. We evaluated the feasibility of a randomized controlled trial to compare levothyroxine to placebo on the variation of left ventricular ejection fraction, in hemodynamically unstable donors. METHODS: We conducted a pilot, double-blinded, randomized controlled trial. Deceased donors with reduced left ventricular ejection fraction or needing vasopressors were included. We randomized participants to a 20 μg bolus followed by a 20 μg/h infusion of levothyroxine or an identically appearing placebo. We report the proportion of recruited participants, the time to the administration of the study drug, and protocol violations. RESULTS: Twenty-four participants (N = 24/104; 23.1%) were eligible. Five of them (N = 5/24; 20.8%) were excluded by the attending physician. Four others were not included, due to family refusal for research (n = 2/24;8.3%) and unavailability of research staff (n = 2/24; 8.3%). Fifteen participants were randomized (N = 15/104; 14.4%). Mean time between the echocardiography and the initiation of the drug was 1.73 hours, and14 (93.3%) of 15 of the participants received the drug within 2 hours after the echocardiography. We report no study violation. The study was stopped prematurely because of low recruitment. CONCLUSION: This pilot trial suggests that the success of a definitive randomized control trial to assess the efficacy of levothyroxine in deceased donors could benefit from a multicenter recruitment and education on the evidence surrounding the pharmacological management of organ donors. The need for consent to research interventions in deceased donors should also be clarified.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".