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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02581111
Other study ID # ODRC-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2015
Est. completion date September 25, 2017

Study information

Verified date July 2020
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Naloxone has been used by many OPOs for decades to improve the pulmonary status of brain-dead organ donors (based on anecdotal evidence and small uncontrolled studies). Its efficacy in this population has never been assessed in a controlled clinical trial. The rationale for its use appears to be that it blocks the increase in capillary permeability that occurs with herniation and brain death (as demonstrated in a single sheep study of herniation). Investigators aim to rigorously test this hypothesis in a randomized placebo-controlled trial in brain-dead organ donors who have baseline hypoxemia. The primary outcome will be the acute change in oxygenation (on first follow-up ABG after naloxone as well as the final ABG prior to organ recovery). Investigators will also assess whether treatment results in more lungs being recovered and transplanted, after correcting for baseline variables such as age, blood group, smoking history, and cause of death. This study will be performed under the auspices of the Organ Donation Research Consortium and be carried out by multiple OPOs across the country. Naloxone or blinded placebo (identical syringe filled with saline) will be given after the baseline ABG shows hypoxemia (PFR - PaO2 divided by FiO2, on positive end-expiratory pressure [PEEP] of 5 and usually 100% FiO2). Naloxone and placebo will both be co-administered with a neuromuscular blocking agent (e.g. vecuronium, per center protocol) to obviate any increase in spinal reflex movements that may be potentiated by naloxone treatment. All other protocols for organ donor management should be maintained at each OPO and no other study interventions are required. Transplant centers will be informed (through DonorNet) that the organ donor being considered for lung recovery has been enrolled in this blinded clinical trial.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone
Naloxone 8-mg IV bolus
Normal saline


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

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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