Naloxone for Optimizing Hypoxemia Of Lung Donors

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Brain Death, Organ Donors, Lung Transplantation

In brief

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.

Key facts

Study ID

NCT02581111

Run by

Washington University School of Medicine

People needed

199

Starts

2015-09-01

Expected to finish

2017-09-25

Last updated by the study team

2020-07-31

Who can join

Age: 13 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No authorization for research
• Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease [COPD], human immunodeficiency virus [HIV] infection)

Where it is running

• Donor Alliance — Denver, Colorado, United States
• Louisiana Organ Procurement Agency — Metairie, Louisiana, United States
• Mid-America Transplant Services — St Louis, Missouri, United States
• Lifeline of Ohio — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.