Trial Outcomes & Findings for Naloxone for Optimizing Hypoxemia Of Lung Donors (NCT NCT02581111)
NCT ID: NCT02581111
Last Updated: 2020-07-31
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
199 participants
Primary outcome timeframe
Baseline and at time of organ recovery, within 72 hours
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
Naloxone
Naloxone 8-mg IV given once after baseline ABG
Naloxone: Naloxone 8-mg IV bolus
|
Placebo
Equivalent volume of saline given once
Normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
101
|
|
Overall Study
COMPLETED
|
96
|
94
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naloxone for Optimizing Hypoxemia Of Lung Donors
Baseline characteristics by cohort
| Measure |
Naloxone
n=98 Participants
Naloxone 8-mg IV given once after baseline ABG
Naloxone: Naloxone 8-mg IV bolus
|
Placebo
n=101 Participants
Equivalent volume of saline given once
Normal saline
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 13 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 13 • n=7 Participants
|
37 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
101 participants
n=7 Participants
|
199 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at time of organ recovery, within 72 hoursChange 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
Outcome measures
| Measure |
Naloxone
n=96 Participants
Naloxone 8-mg IV given once after baseline ABG
Naloxone: Naloxone 8-mg IV bolus
|
Placebo
n=94 Participants
Equivalent volume of saline given once
Normal saline
|
|---|---|---|
|
Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG)
|
81 mm Hg
Interval 19.0 to 176.0
|
80 mm Hg
Interval -13.0 to 189.0
|
SECONDARY outcome
Timeframe: At time of organ recovery (within 72 hours)Whether one or both lungs were transplanted from this organ donor (dichotomized)
Outcome measures
| Measure |
Naloxone
n=98 Participants
Naloxone 8-mg IV given once after baseline ABG
Naloxone: Naloxone 8-mg IV bolus
|
Placebo
n=101 Participants
Equivalent volume of saline given once
Normal saline
|
|---|---|---|
|
Number of Participants Who Had Lungs Transplanted
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline and ABG at 4-6 hours after interventionChange in PaO2:FiO2 ratio from ABG at 4-6 hours after randomization compared to baseline prior to randomization
Outcome measures
| Measure |
Naloxone
n=98 Participants
Naloxone 8-mg IV given once after baseline ABG
Naloxone: Naloxone 8-mg IV bolus
|
Placebo
n=101 Participants
Equivalent volume of saline given once
Normal saline
|
|---|---|---|
|
Acute Change in Oxygenation (P/F Ratio)
|
71 mm Hg
Interval -9.0 to 129.0
|
33 mm Hg
Interval -12.0 to 111.0
|
Adverse Events
Naloxone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rajat Dhar
Washington University in St. Louis School of Medicine
Phone: 3143622999
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place