General public

Revisions to the ASTER Study

On June 15, 2022, the study was paused due to publication of the a the results of the Lessening Organ dysfunction with Vitamin C trial (LOVIT) and the simultaneous publication of a systematic review of all relevant trials of Vitamin C before it. Taken together, these two publications demonstrated that intravenous Vitamin C at the dose used in ASTER was not effective for patients with sepsis. Accordingly, the Vitamin C arm of the trial was stopped on June 15th and a revised study protocol studying acetaminophen versus placebo was proposed by PETAL investigators and approved by the NHLBI and the Institutional Review Board overseeing PETAL studies. Enrollment began in the revised trial on August 16, 2022. Publication of the Vitamin C results from the ASTER trial will follow completion of data collection and analysis in the Fall of 2022.

What is ASTER?

Many patients hospitalized sepsis develop organ failure, including acute lung injury (ARDS), kidney injury, and cardiovascular dysfunction. This study aims to test whether acetaminophen (also known as Tylenol) 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 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.

Trial Summary:

Purpose:

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.

Study Design:

ASTER is a randomized placebo-controlled double-blinded interventional trial of intravenous acetaminophen for patients with sepsis-induced hypotension or respiratory failure.

Primary Objectives

To determine if acetaminophen can increase number of days alive and free of assisted ventilation, vasopressors, or new renal replacement therapy over the first 28 days.

Secondary Objectives

• To determine ventilator, vasopressor, new renal replacement and hospital “free days”
• To determine mortality, duration of ICU stay, development of respiratory failure, and blood tests over study period

Study Size:

This study will enroll approximately 450 patients across 2 treatment assignments.