Rapid Administration of Carnitine in sEpsis
Public ClinicalTrials.gov record NCT01665092. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01665092
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2013 (Type not available)
- Primary completion
- Mar 2018 (Actual)
- Completion
- Mar 2019 (Actual)
- Last update posted
- Jun 4, 2019
2013 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | — | — |
| Univeristy of California Davis | Sacramento | California | — | — |
| Christiana Care Health Services | Wilmington | Delaware | — | — |
| University of Florida | Jacksonville | Florida | — | — |
| Northwestern University | Chicago | Illinois | — | — |
| Indiana University | Indianapolis | Indiana | — | — |
| BIDMC | Boston | Massachusetts | — | — |
| BWH | Boston | Massachusetts | — | — |
| MGH | Boston | Massachusetts | — | — |
| St. Vincent Hospital | Worcester | Massachusetts | — | — |
| Wayne State University | Detroit | Michigan | — | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 29316 | — |
| Cooper University Hospital | Camden | New Jersey | — | — |
| Carolinas Medical Center | Charlotte | North Carolina | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01665092, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2019 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01665092 live on ClinicalTrials.gov.