A Phase 1/2 interventional study of Acetyl-L-Carnitine in Septic Shock, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Vanderbilt University · Phase 1/2, Interventional, and Treatment
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.
This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
Drug: Acetyl-L-Carnitine
Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
Drug: Acetyl-L-Carnitine
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Also known as: ALC
Mean Arterial Blood Pressure
Mean Arterial blood pressure measured non-invasively at 18 hours
Time frame: 18 hours
Vasopressor Dose
Change in vasopressor dose between 6 and 24 hours.
Time frame: 6-24 hours
Serum Lactate
Latest serum lactate between 12 and 36 hours
Time frame: 12-36 hours
| Milestone | Placebo Then ALC | ALC Then Placebo |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
Mean Arterial blood pressure measured non-invasively at 18 hours
| mm Hg | Acetyl-L-Carnitine (ALC) Then Placebo | Placebo Then Acetyl-L-Carnitine (ALC) |
|---|---|---|
| Mean Arterial Blood Pressure | 60 ± 3 | 60 ± 4 |
Change in vasopressor dose between 6 and 24 hours.
| mcg/kg/min | Placebo Then ALC | ALC Then Placebo |
|---|---|---|
| Vasopressor Dose | -1.4 ± 4.4 | -4.8 ± 5.9 |
Latest serum lactate between 12 and 36 hours
| mg/dL | Placebo Then ALC | ALC Then Placebo |
|---|---|---|
| Serum Lactate | 2.1 ± 1.7 | 2.0 ± 1.8 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Then ALC | — | 0/6 (0%) | 0/6 (0%) |
| ALC Then Placebo | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Placebo Then ALC | ALC Then Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 12 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Placebo Then ALC | ALC Then Placebo | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 4 | 5 | 9 |
| Region of Enrollment(participants) | Placebo Then ALC | ALC Then Placebo | Total |
|---|---|---|---|
| United States | 6 | 7 | 13 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University