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You are at:Home » Next Phase of Human Clinical Trials for Revolutionary Sepsis Treatment Commences
Next Phase Of Human Clinical Trials For Revolutionary Sepsis Treatment
Science December 17, 2023

Next Phase of Human Clinical Trials for Revolutionary Sepsis Treatment Commences

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Scientists have developed a promising treatment for sepsis, and clinical trials using sodium ascorbate, a vitamin C preparation, have shown effective results. The treatment has progressed into extensive clinical trials across Australia and demonstrated significant improvements in sepsis patients, including improved kidney function and reduced dependence on other drugs. This breakthrough, the result of decades of research, brings hope to a disease that is the leading cause of death in intensive care units around the world.

Flory Institute researchers, in collaboration with hospital intensivists, have demonstrated that sodium ascorbate, a pH-balanced formulation of vitamin C, is effective in treating sepsis.

Researchers at the Florey Institute have demonstrated that the formulation they have developed reduces deadly sepsis, and the next phase of clinical trials is set to begin across Australia next month.

Promising results from early clinical trial conducted at Melbourne’s Austin Hospital published in journal Critical carehave shown that sodium ascorbate, a pH-balanced formulation of vitamin C, is effective in treating sepsis.

Lead researcher Associate Professor Yugish Lankadeva said sepsis is notoriously difficult to treat and is often fatal.

Clive May, Rinaldo Bellomo, Yugish Lankadeva

LR Florey Professor Clive May, Austin Health Intensivist Professor Rinaldo Bellomo and Florey Associate Professor Yugish Rankadeva discovered that sodium ascorbate can be used to treat sepsis.Credit: Flory

Challenges in sepsis treatment

“Sepsis accounts for 35 to 50 percent of all hospital deaths. It is when the immune system is unable to fight the underlying infection, causing a life-threatening drop in blood pressure, multiple organ failure, and death. ,” said Associate Professor Lankadeva. In our clinical trial at Austin Hospital, sodium ascorbate was administered into patients’ bloodstreams, resulting in promising improvements in multiple organs. ”

Associate Professor Lankadeva, Florey’s research director for Systems Neuroscience, said of the next steps: $4.9 million government-funded research project Delivered in intensive care units in Adelaide, Melbourne, Perth, Brisbane, Alice Springs and Sydney.

“We will recruit 300 adult sepsis patients who will receive either our formulation or a placebo in addition to their usual hospital care. These results will provide additional data to determine the efficacy of the formulation. It will help in collection,” said Associate Professor Lankadeva.

Sodium ascorbate

Flory scientists have created a special formulation of sodium ascorbate to treat sepsis.Credit: Flory

Insights into previous trials

Professor Rinaldo Bellomo, director of intensive care research at Austin Hospital, said the first part of the trial at his department involved 30 adult sepsis patients between October 2020 and November 2022.

While in intensive care in the hospital, half of the patients were randomly assigned to receive sodium ascorbate, and the other half received a placebo.

This study found that patients with sepsis treated with sodium ascorbate:

  • Signs that more urine is produced and kidney function has improved
  • Less need for noradrenaline, a drug used clinically to restore blood pressure
  • He showed signs of improved function in multiple organs.

“Sepsis is the number one cause of death in intensive care units in Australia and around the world,” Professor Bellomo said. “In many cases, the disease progresses so rapidly that by the time patients reach us, they are already seriously ill. It will be a huge change.”

Decades of research bear fruit

Professor Clive May, Florey Senior Research Fellow on the project, has been researching how sepsis causes organ failure, particularly damage to the brain and kidneys, for more than 20 years.

“By showing decreased oxygen levels in the tissues of sepsis, we found that sodium ascorbate was a possible treatment.

“We have seen dramatic results in preclinical studies, where extremely high doses of sodium ascorbate caused complete recovery within just three hours with no side effects. It’s heartening to see that it’s paying off and bringing treatments into the hands of patients,” said Professor Clive May.

Surviving sepsis: The patient’s perspective

Longtime Flory staffer Brett Purcell serves as the consumer representative for the MEGASCORES research program, providing a valuable perspective from sepsis survivors.

“In 2011 I was taken to the hospital by ambulance with high fever and delirium. I was suffering from the early stages of sepsis. My condition gradually worsened and I was transferred to a larger hospital after 12 days. By that time My heart was severely infected and I was in septic shock. Six months ago I had a successful aortic valve replacement. Unfortunately the valve was infected.

“The surgical team repaired the damage in a six-hour operation, but my condition deteriorated to critical condition. I was told it would be an hour. It was the good decision-making of the surgical team and ICU intensivist that saved me. I was put on life support with an ECMO machine and dialysis, and my symptoms rapidly worsened. Improved.

“After almost eight weeks in the hospital, I’m home. I’m really lucky to be alive and hope this new research using sodium ascorbate is less invasive, faster, and extremely effective in fighting sepsis.” We hope to provide hospitals with a new and effective life-saving tool.”

Reference: “Ultra-dose sodium ascorbate: pilot, single-dose, physiological effects, double-blind, randomized, controlled trial” Fumitaka Yanase, Sofia Spano, Akinori Maeda, Anis Chaba, Thummaporn Naorungroj, Connie Pei Chen Ow , Yugeesh R. Rankadeva, Clive N. May, Ashenafi H. Betley, Darius JR Lane, Glenn M. Eastwood, Mark P. Plummer, Rinaldo Bellomo, October 12, 2023. Critical care.
DOI: 10.1186/s13054-023-04644-x

Source: scitechdaily.com

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