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Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis

NCT ID: NCT01739361

Last Updated: 2017-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetaminophen

Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Placebo

Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Acetaminophen

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and Female \>=18 years old
* Admitted to an Intensive Care Unit
* Severe Sepsis
* Detectable plasma cell-free hemoglobin

Exclusion Criteria

* patients who received acetaminophen in the past 48 hours prior to enrollment
* intolerance or allergy to acetaminophen
* measured AST/ALT \>400 U/L in the 24 hours prior to enrollment
* chronic liver disease defined by a Child-Pugh score \>4
* cannot swallow or have no enteral feeding access
* patients with no detectable cell-free hemoglobin
* patients transitioned to palliative care
* pregnant patients or women of childbearing potential without a documented pregnancy test
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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David Janz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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APAP-121486

Identifier Type: -

Identifier Source: org_study_id