A new phase of clinical trials is about to be rolled out for a promising new treatment for sepsis which the researchers say could save countless lives.
“Sepsis is a very complicated and deadly medical condition that leads to multi organ dysfunction … I’ve been researching sepsis for over 10 years,” lead investigator, The Florey Associate Professor Yugeesh Lankadeva told Cosmos.
“About 25,000 people get affected in Australia, but around the world it affects about 50 million people.”
Sepsis starts with an infection, usually bacterial. But instead of your body fighting the infection, the immune system begins to damage its own tissues and organs.
If left untreated, organs start to shut down, and this can be deadly.
“Sepsis is the biggest killer in intensive care units in Australia and worldwide,” Austin Hospital’s Director of Intensive Care Research, Professor Rinaldo Bellomo said.
“It often develops so quickly that patients are already critically ill by the time they reach us. A treatment that acts quickly, is safe and highly effective would be an absolute game-changer.”
The new treatment is called sodium ascorbate – a PH balanced version of vitamin C – and delivered in what scientists call a ‘mega-dose’ into the blood stream.
It’s worth noting that this is the equivalent of thousands of oranges worth of vitamin C, and you can’t just take a few Vitamin C pills to cure sepsis.
The phase 1 clinical trial, the results of which have just been published in Critical Care, treated 30 patients in the Austin Hospital in Melbourne – 15 with sodium ascorbate and 15 with a placebo.
Importantly the trial was randomised and double blind, meaning that neither the doctor giving the treatment, or the patient knew which treatment they were getting.
Those who were given 60 grams of sodium ascorbate showed lowered sequential organ failure assessment score and increased urine output, both of which suggest that kidney and other organs were improving.
“What we found was that an infusion of megadose sodium ascorbate directly into the bloodstream was safe,” Lankadeva told Cosmos.
“It also gave us really strong physiological signals of benefit towards improving kidney function, it reduced blood pressure maintaining drugs, it also showed signals for improving multi organ function.”
This is partially due to the way sodium ascorbate works. In pre-clinical trials, the researchers found that sodium ascorbate is an innate immune cell stimulant, and they believe that the drug is adding huge amounts of antioxidants into the bloodstream to combat oxidative stress.
The team is now moving into a larger 300 patient phase 2 clinical trial across Australia, which starts next month and will focus on the efficacy of the drug.
“In 2023, we received a $4.9 million medical research Future Fund grant from the Australian Federal Government to now advance this promising therapy to larger multicentre clinical trials across mainland Australia,” Lankadeva told Cosmos.
“This phase two trial will determine the efficacy of this drug towards reducing multi-organ dysfunction and death in intensive care units.”
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