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NCT01739361 · ClinicalTrials.gov registry record · Phase 2
Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01739361 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 44 participants.
The verdict
NCT01739361, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased risk of death. Acetaminophen may have a protective effect in these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults with severe sepsis and detectable cell-free hemoglobin. The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation, as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin treated with acetaminophen will have better clinical outcomes, including decreased incidence of acute kidney injury and lower rates of hospital mortality, compared to those who receive placebo.
Interventions
- DRUG Acetaminophen
- DRUG placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01739361
The ClinicalTrials.gov registry entry for NCT01739361 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT01739361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01739361 about?
NCT01739361 is a clinical study titled "Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis". Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased ris...
What is the current status of trial NCT01739361?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2013-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01739361?
The interventions under investigation include: Acetaminophen (DRUG), placebo (DRUG).
Who is sponsoring clinical trial NCT01739361?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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