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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Normal saline |
|
| Carnitine Low | Experimental | Levo-Carnitine 6g |
|
| Carnitine Medium | Experimental | Levo-Carnitine 12 g |
|
| Carnitine High | Experimental | Levo-Carnitine 18 g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levo-Carnitine | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Delta SOFA Score | 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. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Jones, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | United States | |||
| Univeristy of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30646314 | Derived | Jones AE, Puskarich MA, Shapiro NI, Guirgis FW, Runyon M, Adams JY, Sherwin R, Arnold R, Roberts BW, Kurz MC, Wang HE, Kline JA, Courtney DM, Trzeciak S, Sterling SA, Nandi U, Patki D, Viele K. Effect of Levocarnitine vs Placebo as an Adjunctive Treatment for Septic Shock: The Rapid Administration of Carnitine in Sepsis (RACE) Randomized Clinical Trial. JAMA Netw Open. 2018 Dec 7;1(8):e186076. doi: 10.1001/jamanetworkopen.2018.6076. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Normal saline placebo |
| FG001 | Carnitine Low | Levo-Carnitine 6g Levo-Carnitine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 |
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| Drug |
|
| Sacramento |
| California |
| United States |
| Christiana Care Health Services | Wilmington | Delaware | United States |
| University of Florida | Jacksonville | Florida | United States |
| Northwestern University | Chicago | Illinois | United States |
| Indiana University | Indianapolis | Indiana | United States |
| BIDMC | Boston | Massachusetts | United States |
| BWH | Boston | Massachusetts | United States |
| MGH | Boston | Massachusetts | United States |
| St. Vincent Hospital | Worcester | Massachusetts | United States |
| Wayne State University | Detroit | Michigan | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 29316 | United States |
| Cooper University Hospital | Camden | New Jersey | United States |
| Carolinas Medical Center | Charlotte | North Carolina | United States |
| FG002 |
| Carnitine Medium |
Levo-Carnitine 12 g Levo-Carnitine |
| FG003 | Carnitine High | Levo-Carnitine 18 g Levo-Carnitine |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Normal saline placebo |
| BG001 | Carnitine Low | Levo-Carnitine 6g Levo-Carnitine |
| BG002 | Carnitine Medium | Levo-Carnitine 12 g Levo-Carnitine |
| BG003 | Carnitine High | Levo-Carnitine 18 g Levo-Carnitine |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Delta SOFA Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
|
28 days
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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 | Control | Normal saline placebo | 34 | 75 | 0 | 75 | 0 | 75 |
| EG001 | Carnitine Low | Levo-Carnitine 6g Levo-Carnitine | 20 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Carnitine Medium | Levo-Carnitine 12 g Levo-Carnitine | 16 | 34 | 0 | 34 | 0 | 34 |
| EG003 | Carnitine High | Levo-Carnitine 18 g Levo-Carnitine | 45 | 106 | 0 | 106 | 0 | 106 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Jones | Univeristy of Mississippi Medical Center | 601-384-5586 | aejones@umc.edu |
| May 16, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|