Lung Transplantation Clinical Trial
— NO-HOLDSOfficial title:
Randomized Placebo-controlled Trial of Intravenous Naloxone to Improve Oxygenation in Hypoxemic Lung-Eligible Brain-Dead Organ Donors
Verified date | July 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 199 |
Est. completion date | September 25, 2017 |
Est. primary completion date | September 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Lifeline of Ohio | Columbus | Ohio |
United States | Donor Alliance | Denver | Colorado |
United States | Louisiana Organ Procurement Agency | Metairie | Louisiana |
United States | Mid-America Transplant Services | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Dhar R, Stahlschmidt E, Paramesh A, Marklin G. A Randomized Controlled Trial of Naloxone for Optimization of Hypoxemia in Lung Donors After Brain Death. Transplantation. 2019 Jul;103(7):1433-1438. doi: 10.1097/TP.0000000000002511. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline and at time of organ recovery, within 72 hours | |
Secondary | Number of Participants Who Had Lungs Transplanted | Whether one or both lungs were transplanted from this organ donor (dichotomized) | At time of organ recovery (within 72 hours) | |
Secondary | 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 | Baseline and ABG at 4-6 hours after intervention |
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