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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 is a Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 31 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01193777
The ClinicalTrials.gov registry entry for NCT01193777 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01193777 reports 0 study locations.
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.
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