Septic Shock
Conditions
Keywords
Septic shock, Acetyl-L-carnitine
Brief summary
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.
Detailed description
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.
Interventions
Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* documented or presumed infection * shock requiring vasopressors
Exclusion criteria
* dialysis * hepatic failure * seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Blood Pressure | 18 hours | Mean Arterial blood pressure measured non-invasively at 18 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor Dose | 6-24 hours | Change in vasopressor dose between 6 and 24 hours. |
| Serum Lactate | 12-36 hours | Latest serum lactate between 12 and 36 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then ALC Placebo for first 6 hours then ALC for 12 hours | 6 |
| ALC Then Placebo ALC for first 12 hours then placebo for next 6 hours | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Placebo Then ALC | ALC Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Mean Arterial Blood Pressure
Mean Arterial blood pressure measured non-invasively at 18 hours
Time frame: 18 hours
Population: All patients treated. Intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetyl-L-Carnitine (ALC) Then Placebo | Mean Arterial Blood Pressure | 60 mm Hg | Standard Error 3 |
| Placebo Then Acetyl-L-Carnitine (ALC) | Mean Arterial Blood Pressure | 60 mm Hg | Standard Error 4 |
Secondary
Serum Lactate
Latest serum lactate between 12 and 36 hours
Time frame: 12-36 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetyl-L-Carnitine (ALC) Then Placebo | Serum Lactate | 2.1 mg/dL | Standard Deviation 1.7 |
| Placebo Then Acetyl-L-Carnitine (ALC) | Serum Lactate | 2.0 mg/dL | Standard Deviation 1.8 |
Secondary
Vasopressor Dose
Change in vasopressor dose between 6 and 24 hours.
Time frame: 6-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetyl-L-Carnitine (ALC) Then Placebo | Vasopressor Dose | -1.4 mcg/kg/min | Standard Deviation 4.4 |
| Placebo Then Acetyl-L-Carnitine (ALC) | Vasopressor Dose | -4.8 mcg/kg/min | Standard Deviation 5.9 |