Trial · NCT02581111
Naloxone for Optimizing Hypoxemia Of Lung Donors
NCT02581111, Phase 2, Phase 3, Completed, Washington University School of Medicine; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Naloxone for Optimizing Hypoxemia Of Lung Donors. Trials, record NCT02581111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02581111
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naloxone for Optimizing Hypoxemia Of Lung Donors
- NCT number
- NCT02581111
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Brain Death, Organ Donors, Lung Transplantation
- Interventions
- Naloxone, Normal saline
- First posted
- 2015-10-20
- Last updated
- 2020-07-31
- Results first posted
- 2018-10-16
- Limitations and caveats
- 10 subjects were enrolled despite baseline PaO2:FiO2 ratio above 300 (i.e. protocol violations)
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) | Baseline and at time of organ recovery, within 72 hours | Change in ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) from final ABG performed before organ recovery compared to baseline ABG |
| Secondary | Number of Participants Who Had Lungs Transplanted | At time of organ recovery (within 72 hours) | Whether one or both lungs were transplanted from this organ donor (dichotomized) |
| Secondary | Acute Change in Oxygenation (P/F Ratio) | Baseline and ABG at 4-6 hours after intervention | Change in PaO2:FiO2 ratio from ABG at 4-6 hours after randomization compared to baseline prior to randomization |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) | Baseline and at time of organ recovery, within 72 hours | mm Hg | MEDIAN | |
| SECONDARY | Number of Participants Who Had Lungs Transplanted | At time of organ recovery (within 72 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Acute Change in Oxygenation (P/F Ratio) | Baseline and ABG at 4-6 hours after intervention | mm Hg | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) | Naloxone | 81 | Inter-Quartile Range 19 to 176 | mm Hg | |
| Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) | Placebo | 80 | Inter-Quartile Range -13 to 189 | mm Hg | |
| Number of Participants Who Had Lungs Transplanted | Naloxone | 19 | Participants | ||
| Number of Participants Who Had Lungs Transplanted | Placebo | 19 | Participants | ||
| Acute Change in Oxygenation (P/F Ratio) | Naloxone | 71 | Inter-Quartile Range -9 to 129 | mm Hg | |
| Acute Change in Oxygenation (P/F Ratio) | Placebo | 33 | Inter-Quartile Range -12 to 111 | mm Hg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naloxone | 98 | |
| Overall Study | STARTED | Placebo | 101 | |
| Overall Study | COMPLETED | Naloxone | 96 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | NOT COMPLETED | Naloxone | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naloxone | 0 | 98 |
| Total, all-cause mortality | Placebo | 0 | 101 |
| Total, other adverse events | Naloxone | 0 | 98 |
| Total, other adverse events | Placebo | 0 | 101 |
| Total, serious adverse events | Naloxone | 0 | 98 |
| Total, serious adverse events | Placebo | 0 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30399122 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Naloxone vs Placebo: Number of Participants Who Had Lungs Transplanted | Trial comparisons |
| Naloxone vs Placebo: deaths from any cause | Trial comparisons |
| Naloxone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02581111
GET https://conductscience.org/api/trials/v1/NCT02581111/registered