NCT02581111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 16, 2018

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

October 1, 2015

Results QC Date

August 20, 2018

Last Update Submit

July 16, 2020

Conditions

Brain DeathOrgan DonorsLung Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants Who Had Lungs Transplanted

    At time of organ recovery (within 72 hours)

  • Acute Change in Oxygenation (P/F Ratio)

    Baseline and ABG at 4-6 hours after intervention

Study Arms (2)

Naloxone

EXPERIMENTAL

Naloxone 8-mg IV given once after baseline ABG

Drug: Naloxone

Placebo

SHAM COMPARATOR

Equivalent volume of saline given once

Drug: Normal saline

Interventions

NaloxoneDRUG

Naloxone 8-mg IV bolus

Also known as: Narcan
Naloxone
Normal salineDRUG
Also known as: saline
Placebo

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Donor Alliance

Denver, Colorado, 80246, United States

Location

Louisiana Organ Procurement Agency

Metairie, Louisiana, 70002, United States

Location

Mid-America Transplant Services

St Louis, Missouri, 63110, United States

Location

Lifeline of Ohio

Columbus, Ohio, 43212, United States

Location

Related Publications (1)

  • 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.

    PMID: 30399122RESULT

MeSH Terms

Conditions

Brain Death

Interventions

NaloxoneSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

10 subjects were enrolled despite baseline PaO2:FiO2 ratio above 300 (i.e. protocol violations)

Results Point of Contact

Title
Dr. Rajat Dhar
Organization
Washington University in St. Louis School of Medicine
dharr@neuro.wustl.edu
3143622999

Study Officials

  • Rajat Dhar, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

September 22, 2017

Study Completion

September 25, 2017

Last Updated

July 31, 2020

Results First Posted

October 16, 2018

Record last verified: 2020-07

Locations

US(4)