Phase 3
Completed N=199
Naloxone for Optimizing Hypoxemia Of Lung Donors
Brain Death · Organ Donors · Lung Transplantation
Source: ClinicalTrials.gov NCT02581111 ↗
Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) — 81; 80 mm Hg
◆ Published Evidence
Established
23citations · ~3 / year
A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors After Brain Death.
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.
Linked Publications
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A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors After Brain Death.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) |
81; 80 | — |
| SECONDARY Number of Participants Who Had Lungs Transplanted |
19; 19 | — |
| SECONDARY Acute Change in Oxygenation (P/F Ratio) |
71; 33 | — |
Eligibility Criteria
Inclusion Criteria
- Brain-dead organ donor being managed by OPO (organ procurement organization)
- Lungs being considered for recovery and transplant
- Baseline ABG (after authorization) with P/F ratio < 300
Exclusion Criteria
- No authorization for research
- Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease [COPD], human immunodeficiency virus [HIV] infection)
Data sourced from ClinicalTrials.gov (NCT02581111) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.