Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis (ACROSS)
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|ClinicalTrials.gov Identifier: NCT01739361|
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : March 23, 2015
Last Update Posted : December 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Drug: Acetaminophen Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase IIa Randomized Controlled Trial of Acetaminophen for the Reduction of Oxidative Stress in Severe Sepsis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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.
Placebo Comparator: Placebo
Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
- F2-isoprostanes After 72 Hours of Acetaminophen or Placebo [ Time Frame: 72 hours after randomization ]F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.
- In-hospital Mortality [ Time Frame: Patients will be followed through the end of their hospital stay, an average of 5 weeks ]percent of patients who died in the hospital
- Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo [ Time Frame: 72 hours ]serum creatinine measurements at 72 hours
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739361
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|