A Phase 2/3 interventional study of Naloxone and Normal saline in Brain Death, Organ Donors and Lung Transplantation, sponsored by Washington University School of Medicine. Completed at 4 sites in United States. Open to participants aged 13 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by Washington University School of Medicine · Phase 2/3, Interventional, and Treatment
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.
Naloxone has been used by many OPOs for decades to improve the pulmonary status of brain-dead organ donors (based on anecdotal evidence and small uncontrolled studies). Its efficacy in this population has never been assessed in a controlled clinical trial. The rationale for its use appears to be that it blocks the increase in capillary permeability that occurs with herniation and brain death (as demonstrated in a single sheep study of herniation). Investigators aim to rigorously test this hypothesis in a randomized placebo-controlled trial in brain-dead organ donors who have baseline hypoxemia. The primary outcome will be the acute change in oxygenation (on first follow-up ABG after naloxone as well as the final ABG prior to organ recovery). Investigators will also assess whether treatment results in more lungs being recovered and transplanted, after correcting for baseline variables such as age, blood group, smoking history, and cause of death. This study will be performed under the auspices of the Organ Donation Research Consortium and be carried out by multiple OPOs across the country. Naloxone or blinded placebo (identical syringe filled with saline) will be given after the baseline ABG shows hypoxemia (PFR - PaO2 divided by FiO2, on positive end-expiratory pressure [PEEP] of 5 and usually 100% FiO2). Naloxone and placebo will both be co-administered with a neuromuscular blocking agent (e.g. vecuronium, per center protocol) to obviate any increase in spinal reflex movements that may be potentiated by naloxone treatment. All other protocols for organ donor management should be maintained at each OPO and no other study interventions are required. Transplant centers will be informed (through DonorNet) that the organ donor being considered for lung recovery has been enrolled in this blinded clinical trial.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 199 is above the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Naloxone 8-mg IV given once after baseline ABG
Drug: Naloxone
Equivalent volume of saline given once
Drug: Normal saline
Naloxone 8-mg IV bolus
Also known as: Narcan
Also known as: saline
Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG)
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
Time frame: Baseline and at time of organ recovery, within 72 hours
Number of Participants Who Had Lungs Transplanted
Whether one or both lungs were transplanted from this organ donor (dichotomized)
Time frame: At time of organ recovery (within 72 hours)
Acute Change in Oxygenation (P/F Ratio)
Change in PaO2:FiO2 ratio from ABG at 4-6 hours after randomization compared to baseline prior to randomization
Time frame: Baseline and ABG at 4-6 hours after intervention
| Milestone | Naloxone | Placebo |
|---|---|---|
| Started | 98 | 101 |
| Completed | 96 | 94 |
| Not completed | 2 | 7 |
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
| mm Hg | Naloxone | Placebo |
|---|---|---|
| Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG) | 81 (19 to 176) | 80 (-13 to 189) |
Whether one or both lungs were transplanted from this organ donor (dichotomized)
| Participants | Naloxone | Placebo |
|---|---|---|
| Number of Participants Who Had Lungs Transplanted | 19 | 19 |
Change in PaO2:FiO2 ratio from ABG at 4-6 hours after randomization compared to baseline prior to randomization
| mm Hg | Naloxone | Placebo |
|---|---|---|
| Acute Change in Oxygenation (P/F Ratio) | 71 (-9 to 129) | 33 (-12 to 111) |
Collected over Till organ recovery (maximum of three days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naloxone | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Placebo | 0/101 (0%) | 0/101 (0%) | 0/101 (0%) |
| Age, Continuous(years) | Naloxone | Placebo | Total |
|---|---|---|---|
| Mean | 37.4 ± 13 | 36.8 ± 13 | 37 ± 13 |
| Sex: Female, Male(Participants) | Naloxone | Placebo | Total |
|---|---|---|---|
| Female | 40 | 50 | 90 |
| Male | 58 | 51 | 109 |
| Ethnicity (NIH/OMB)(Participants) | Naloxone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 13 | 18 |
| Not Hispanic or Latino | 87 | 83 | 170 |
| Unknown or Not Reported | 6 | 5 | 11 |
| Race (NIH/OMB)(Participants) | Naloxone | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 20 | 35 |
| White | 77 | 76 | 153 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 5 | 11 |
| Region of Enrollment(participants) | Naloxone | Placebo | Total |
|---|---|---|---|
| United States | 98 | 101 | 199 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Naloxone
Washington University School of Medicine →