NCT02581111: Naloxone for Optimizing Hypoxemia Of Lung Donors

Summary

Brain-dead patients who provide authorization for organ donation will be randomized to naloxone or placebo if baseline arterial blood gas (ABG) after initiation of OPO (Organ Procurement Organization) management reveals hypoxemia, as defined by the ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) below 300 mm Hg, unless they have already been ruled-out for lung recovery. Investigators aim to assess whether naloxone improves oxygenation prior to organ recovery more than placebo.

Timeline

Start: 2015-09
Primary completion: 2017-09-22
Completion: 2017-09-25

Outcome

Missed primary endpoint

paper Both groups exhibited similar improvements in oxygenation (median improvement in PFR of 81 with naloxone versus 80 with saline, P = 0.68) PMID 30399122 ↗

Publications

Results Dhar R, Stahlschmidt E, Paramesh A, Marklin G. A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors After Brain Death. Transplantation. 2019 Jul;103(7):1433-1438. doi: 10.1097/TP.0000000000002511.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	8 mg	Intravenous

Indications

No indication recorded.