Sepsis Clinical Trials 2022

What are Sepsis Clinical Trials?

Sepsis, also known as blood poisoning, is caused by the extreme response of the body’s immune system to an infection. The body attacks its healthy tissues and organs, leading to tissue damage and multiple organ failure. This overactive response is followed by immune system suppression, leaving the body defenseless in the face of further infection. It is a critical, life-threatening condition that can lead to death if not immediately treated. Along with the symptoms of the primary infection, sepsis leads to fever, confusion, and rapid breathing and pulse.

While many people can recover from mild sepsis, they are often plagued with life-long cognitive and health issues. These effects are now known as post-sepsis syndrome (PSS) and include symptoms like physical disabilities, cognitive disabilities, and poor quality of life.

Why Study Sepsis Through Clinical Trials?

Sepsis is a life-threatening condition that develops in 1.7 million Americans yearly, with 20.5% dying while hospitalized or after being discharged. This data shows that the current management methods have room for improvement to decrease the mortality rate.

Clinical trials are vital in developing better treatment plans that are faster, more effective, and can overcome the antibiotic resistance that develops in patients with sepsis. These trials can also improve testing methods so sepsis can be diagnosed in the initial stages, giving a better outcome.

What Are The Types of Treatments Available For Sepsis?

Sepsis is managed with an aggressive treatment plan that involves multiple therapies. As soon as blood cultures are taken, broad-spectrum antibiotics and fluids are given intravenously. Red blood cell transfusions may also be recommended depending on the patient's hemoglobin level.

If the patient goes into septic shock (low blood pressure due to sepsis), vasopressors such as norepinephrine are given to raise the blood pressure. However, too much can be toxic, in which case doctors may also administer epinephrine. If a patient is not brought out of septic shock, it leads to death in 34.7% of cases within 30 days.

Source control is also done by draining pus from abscesses that form inside the body to reduce the growth of microorganisms creating the infection.

What are Some Notable Breakthroughs in Sepsis Clinical Trials?

2019: A review studied clinical data from trials that used corticosteroids to treat septic shock. It found that low doses of hydrocortisone could be beneficial for patients who needed more than 30 μg/min of vasopressors and had at least one case of organ failure. However, it was noted that steroids should be used cautiously and tapered off when no longer required.

2021: A review of data from clinical trials that used vitamin C in sepsis intervention was studied. These trials were based on Dr. Paul E. Marik, Marik Protocol. Now known as the HAT protocol, this treatment proposes using steroids, vitamin C, and thiamine to manage sepsis for patients in ICU. Preliminary conclusions suggest that vitamin C may reduce mortality in patients compared to a placebo group.