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ASTER: Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
What is ASTER?
Many patients hospitalized sepsis develop organ failure, including acute lung injury (ARDS), kindey injury, and cardiovascular dysfunction. This study aims to test whether acetaminophen (also known as Tylenol) and ascorbate (also known as vitamin-C) can improve survival for patients with sepsis.
Who can be in this study?
Adults (age 18 and older) admitted to the ICU with sepsis with hypotension or respiratory failure may be eligible for this study.
What Happens in this study?
- Participants will be randomly assigned to receive Tylenol, vitamin C, or usual care.
- Information will be collected from study participants’ medical records and by phone calls after they leave the hospital at about 3 months
- Some additional blood tests may be performed
Who is paying for this study?
The National Heart, Lung and Blood Institute (NHLBI), which is part of the U.S. government, is paying for this research.
To assess the efficacy of Acetaminophen in comparison to placebo for 120 hours in patients with sepsis who have evidence of either hemodynamic or respiratory organ failure. This trial wil also assess the efficacy of Vitamin C compared to placebo infused intravenously for 120 hours in the same patient population.
ASTER is a randomized placebo-controlled double-blinded interventional trial of intravenous Vitamin C and intravenous acetaminophen) for patients with sepsis-induced hypotension or respiratory failure.
To determine if acetaminophen or Vitamin C can increase number of days alive and free of assisted ventilation, vasopressors, or renal replacement therapy over the first 28 days.
- To determine ventilator, vasopressor, renal replacement and hospital “free days”
- To determine mortality, duration of ICU stay, development of respiratory failure, and blood tests over study period
This study will enroll approximately 900 patients across 4 treatment assignments.