CompletedPhase 2/3

Naloxone for Optimizing Hypoxemia Of Lung Donors

United States199 participantsStarted 2015-09

Plain-language 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.

Who can participate

Age range13 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG)

Timeframe: Baseline and at time of organ recovery, within 72 hours

Trial details

NCT IDNCT02581111

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09-22

Results submitted2018-08-20

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