Naloxone for Optimizing Hypoxemia Of Lung Donors
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 13 - 70 |
| Updated: | 10/18/2018 |
| Start Date: | September 2015 |
| End Date: | September 25, 2017 |
Randomized Placebo-controlled Trial of Intravenous Naloxone to Improve Oxygenation in Hypoxemic Lung-Eligible Brain-Dead Organ Donors
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 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.
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.
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)
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