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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Dec 31, 2012
- Primary completion
- Feb 28, 2018
- Completion
- Feb 28, 2019
- Last update posted
- Jun 3, 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 3, 2019 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01665092 live on ClinicalTrials.gov.