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Clinical trial of new treatment for sepsis?

Sepsis, also known as blood poisoning, is an infection that spans multiple systems of the body, often leading to loss of blood pressure, organ failure, and death. Sepsis is the leading cause of death in hospitals, claiming around 300,000 people per year in the United States. Paul Marik, a doctor in Norfolk, VA developing a new sepsis treatment, says the death rate from the infection is akin to "three jumbo jets crashing every day."

Currently, hospitals treat sepsis by administering fluids and antibiotics. Marik's treatment involves a mix of corticosteroids and two vitamins - Vitamin B and Vitamin C. The combination, Marik says, boosts the body's reception of the steroids,which relieve the inflammation associated with sepsis. Marik says he's treated 150 patients with his custom combo now, and only one has died of sepsis.

Marik's treatment seems miraculous and potentially transformative in the way sepsis is treated - so naturally and rightfully, physicians are wary. A chief concern is that the treatment hasn't been through a randomized double-blind controlled trial, the gold standard of evaluating medical treatments. In such a trial, patients are randomly assigned to receive either the treatment or a placebo, with neither the patient or the doctor aware of who receives what. One physician stated that with the claims Marik has made, even a small study could corroborate them. Ideally, such a study would be carried out at multiple hospitals to ensure the effect could be replicated.

Part of doctors' skepticism comes from the history of sepsis treatments. In 2011, two potential treatments failed due to a lack of clear evidence that they were effective. Both were pharmaceuticals, which proceed through a different approval pathway than Marik's treatment, which does not involve any new drugs, but rather a combination of existing compounds. Marik will have to submit a research proposal for funding, with a review process that could take nine months. Results wouldn't be available for probably two years.

But if the treatment is proven effective, it could save millions of lives and reshape medicine's understanding of how the body responds to inflammation.

Will a randomized, controlled, double-blind trial of Marik's treatment begin before 2019?

This question will resolve as positive if a clinical trial registry such as clinicaltrials.gov or a credible news outlet reports that a trial treatment for sepsis involving corticosteroids and vitamins C and D is underway on or before December 31, 2018.

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