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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: Completed Phase 2 study, sponsored by Vanderbilt University.

NCT01739361 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.

Interventions

  • DRUG Acetaminophen
  • DRUG placebo

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2013-04
Est. Completion 2013-12
Phase Phase 2
Vanderbilt University

430 total trials

What the finished NCT01739361 record still lists

NCT01739361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.

NCT01739361 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01739361's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 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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Source: ClinicalTrials.gov NCT01739361, the US trial registry maintained by the National Library of Medicine. NCT01739361 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.