Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/27/2017 |
| Start Date: | April 2013 |
| End Date: | December 2013 |
Phase IIa Randomized Controlled Trial of Acetaminophen for the Reduction of Oxidative Stress 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 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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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