Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Acetaminophen

Criteria

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