A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors after Brain Death

Background Persistent hypoxemia is the principal reason lungs from otherwise eligible BD organ donors are not transplanted. Experimental models and retrospective studies have suggested that naloxone attenuates neurogenic pulmonary edema and reverses hypoxemia after brain death. We undertook a multi-site randomized placebo-controlled trial to evaluate whether naloxone is able to improve oxygenation in BD donors with hypoxemia. Methods BD organ donors at four OPOs were randomized in a blinded manner to naloxone 8-mg or saline placebo if lung were being considered for allocation but exhibited hypoxemia (PFR below 300 mm Hg). The primary outcome was change in PFR from baseline to final ABG. Secondary outcomes included early improvement in PFR and proportion of lungs transplanted. Results A total of 199 lung-eligible BD donors were randomized to naloxone (n=98) or placebo (n=101). Groups were comparable at baseline. Both groups exhibited similar improvements in oxygenation (median improvement in PFR of 81 with naloxone vs. 80 with saline, p=0.68) with 37 (39%) vs. 38 (40%) exhibiting reversal of hypoxemia. There was no difference in the rate of lungs transplanted (19% in both groups, p=0.97) although it was significantly higher in those with reversal of hypoxemia (32/69 vs. 2/111, p

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