A clinical trial supported by the US National Institutes of Health (NIH) has indicated that intravenous acetaminophen could benefit patients with sepsis.

Sepsis is an extreme and uncontrolled response of the body to an infection, which can lead to severe health complications.

Researchers conducted a mid-stage clinical trial of acetaminophen enrolling 447 adult sepsis patients with respiratory or circulatory organ dysfunction.

The participants were admitted to 40 academic hospitals across the US from October 2021 to April 2023. They were randomly assigned to receive either intravenous acetaminophen or a placebo every six hours for five days.

The primary focus of the study was the number of patients surviving without organ support, such as mechanical ventilation or treatment for kidney failure.

In the trial, intravenous acetaminophen was demonstrated to lower organ injury or acute respiratory distress syndrome development risk in sepsis patients.

The study confirmed that intravenous acetaminophen is safe for sepsis patients, with no increase in liver injury, low blood pressure, or other adverse events when compared to the placebo group.

Additionally, the acetaminophen group exhibited significantly lower instances of organ injury and a reduced rate of acute respiratory distress syndrome within the first seven days of hospital admission.

A closer examination of patients with higher levels of cell-free haemoglobin revealed that only 8% in acetaminophen arm required assisted ventilation versus 23% in the placebo group.

The trial, which did not show an improvement in mortality rates across all trial subjects, highlighted that the greatest benefit of acetaminophen was observed in those most at risk for organ damage.

After 28 days, the mortality rate was 12% in the acetaminophen group versus 21% in the placebo group, though this result did not reach statistical significance.

NIH Division of Lung Diseases at the National Heart, Lung, and Blood Institute director James Kiley said: “While the anticipated effects of acetaminophen therapy were not realised for all sepsis patients, this study shows that it still holds promise for the most critically ill.

“Though, more research is needed to uncover the mechanisms and validate these results.”

A larger trial in sepsis patients with higher cell-free haemoglobin levels is anticipated to commence soon.