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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|