Trial Outcomes & Findings for Rapid Administration of Carnitine in sEpsis (NCT NCT01665092)
NCT ID: NCT01665092
Last Updated: 2019-06-04
Results Overview
Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
48 hours
Results posted on
2019-06-04
Participant Flow
Participant milestones
| Measure |
Control
Normal saline
placebo
|
Carnitine Low
Levo-Carnitine 6g
Levo-Carnitine
|
Carnitine Medium
Levo-Carnitine 12 g
Levo-Carnitine
|
Carnitine High
Levo-Carnitine 18 g
Levo-Carnitine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
35
|
34
|
106
|
|
Overall Study
COMPLETED
|
75
|
35
|
32
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Administration of Carnitine in sEpsis
Baseline characteristics by cohort
| Measure |
Control
n=75 Participants
Normal saline
placebo
|
Carnitine Low
n=35 Participants
Levo-Carnitine 6g
Levo-Carnitine
|
Carnitine Medium
n=34 Participants
Levo-Carnitine 12 g
Levo-Carnitine
|
Carnitine High
n=106 Participants
Levo-Carnitine 18 g
Levo-Carnitine
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.22 years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
67.51 years
STANDARD_DEVIATION 12.01 • n=107 Participants
|
64.91 years
STANDARD_DEVIATION 12.56 • n=206 Participants
|
59.67 years
STANDARD_DEVIATION 14.50 • n=7 Participants
|
62 years
STANDARD_DEVIATION 14 • n=31 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
108 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
142 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
238 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
250 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 48 hoursSequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.
Outcome measures
| Measure |
Control
n=75 Participants
Normal saline
placebo
|
Carnitine Low
n=35 Participants
Levo-Carnitine 6g
Levo-Carnitine
|
Carnitine Medium
n=34 Participants
Levo-Carnitine 12 g
Levo-Carnitine
|
Carnitine High
n=106 Participants
Levo-Carnitine 18 g
Levo-Carnitine
|
|---|---|---|---|---|
|
Delta SOFA Score
|
-1.8 units on a scale
Standard Deviation 0.35
|
-0.34 units on a scale
Standard Deviation 0.66
|
-1.68 units on a scale
Standard Deviation 0.61
|
-2.15 units on a scale
Standard Deviation 0.37
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 34 deaths
Carnitine Low
Serious events: 0 serious events
Other events: 0 other events
Deaths: 20 deaths
Carnitine Medium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Carnitine High
Serious events: 0 serious events
Other events: 0 other events
Deaths: 45 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place