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NCT01193777 · ClinicalTrials.gov registry record · Phase 1
L-Carnitine Administration in Early Sepsis
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01193777: Clinical Trial Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT01193777 is a Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193777, a Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die. The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.
Primary Outcome
SOFA score will be measured at 0 and 24 hours
Interventions
- DRUG Normal Saline
- DRUG L-Carnitine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
Why NCT01193777 stopped before completion
NCT01193777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01193777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01193777 about?
NCT01193777 is a clinical study titled "L-Carnitine Administration in Early Sepsis". Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, w...
What is the current status of trial NCT01193777?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-09. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01193777?
The interventions under investigation include: Normal Saline (DRUG), L-Carnitine (DRUG).
Who is sponsoring clinical trial NCT01193777?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01193777's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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