Phase 3
N=199
Naloxone for Optimizing Hypoxemia Of Lung Donors
Brain Death · Organ Donors · Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02581111 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) — 81; 80 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naloxone (Drug); Normal saline (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Sep 2017
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 | — |
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.
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). 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.