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NCT01665092 · ClinicalTrials.gov registry record · Phase 2
Rapid Administration of Carnitine in sEpsis
A Phase 2 study, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01665092: Completed Phase 2 study, sponsored by University of Mississippi Medical Center.
NCT01665092 is a Phase 2 study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665092, a Phase 2 study, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG placebo
- DRUG Levo-Carnitine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2013-01 |
| Est. Completion | 2019-03 |
| Phase | Phase 2 |
What the finished NCT01665092 record still lists
NCT01665092 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01665092 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01665092 about?
NCT01665092 is a clinical study titled "Rapid Administration of Carnitine in sEpsis". 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 adjunct...
What is the current status of trial NCT01665092?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2013-01. Estimated completion is 2019-03.
What interventions are being tested in trial NCT01665092?
The interventions under investigation include: placebo (DRUG), Levo-Carnitine (DRUG).
Who is sponsoring clinical trial NCT01665092?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01665092's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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