CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 enrolled
Drug / intervention
Naloxone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02581111
NCT02581111Phase 3Completed
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Randomized Placebo-controlled Trial of Intravenous Naloxone to Improve Oxygenation in Hypoxemic Lung-Eligible Brain-Dead Organ Donors

Washington University School of Medicine·interventional·Posted Oct 20, 2015·Updated Jul 31, 2020

In Brief

A Phase 3 clinical trial evaluating Naloxone and Normal saline for Brain Death and 2 related conditions. Completed, enrolled 199 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Death, Organ Donors, Lung Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartSep 1, 2015
Primary CompletionSep 22, 2017
Study CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.7 years ago

Interventions

Naloxonedrug

Naloxone 8-mg IV bolus

Normal salinedrug