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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours |
|
| B | Other | Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetyl-L-Carnitine | Drug | Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure | Mean Arterial blood pressure measured non-invasively at 18 hours | 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor Dose | Change in vasopressor dose between 6 and 24 hours. | 6-24 hours |
| Serum Lactate | Latest serum lactate between 12 and 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd W. Rice, MD, MSc | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then ALC | Placebo for first 6 hours then ALC for 12 hours |
| FG001 | ALC Then Placebo | ALC for first 12 hours then placebo for next 6 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then ALC | Placebo for first 6 hours then ALC for 12 hours |
| BG001 | ALC Then Placebo | ALC for first 12 hours then placebo for next 6 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Blood Pressure | Mean Arterial blood pressure measured non-invasively at 18 hours | All patients treated. Intention to treat. | Posted | Mean | Standard Error | mm Hg | 18 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Then ALC | Placebo for first 6 hours then ALC for 12 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Rice, MD | Vanderbilt University | 615 322-3412 | todd.rice@vanderbilt.edu |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000108 | Acetylcarnitine |
| ID | Term |
|---|---|
| D002331 | Carnitine |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| 12-36 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Vasopressor Dose | Change in vasopressor dose between 6 and 24 hours. | Posted | Mean | Standard Deviation | mcg/kg/min | 6-24 hours |
|
|
|
| Secondary | Serum Lactate | Latest serum lactate between 12 and 36 hours | Posted | Mean | Standard Deviation | mg/dL | 12-36 hours |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | ALC Then Placebo | ALC for first 12 hours then placebo for next 6 hours | 0 | 7 | 0 | 7 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D009930 |
| Organic Chemicals |