Improving septic shock treatment

The international Pragmatic Pediatric Trial of Balanced vs NormaL Saline Fluid in Sepsis will compare two treatments commonly used to treat sepsis in children to compare their safety and effectiveness.

Date published:
General public


Sepsis is a potentially life-threatening illness caused by the body's response to an infection. Also known as septicaemia or blood poisoning, sepsis can lead to shock, organ failure, and death.

Each year, sepsis affects millions children and thousands die from septic shock worldwide. The World Health Organization and the US Centers for Disease Control and Prevention are looking to optimise therapies for this urgent global public health problem.

Comparing sepsis treatments

For decades, health care workers have used normal saline and balanced fluids as intravenous fluids in both children and adults. We use them to restore blood volume, but also for example after severe bleeding or diarrhoea.

‘Normal saline just has water and 2 salts – sodium and chloride,’ Professor Franz Babl, head of the project in Australia, says.

‘It works fine in most conditions. But with sepsis you need high amounts of fluid and the use of saline has a higher risk of renal (kidney) failure.’

‘Balanced fluid is closer to what you find in blood, with several salts instead of just 2 and a lower amount of chloride salt in particular. Studies show that in adults there is a lower mortality rates and lower rates of renal failure with balanced fluids.

‘But in medicine you can rarely translate directly from adults to children. Children will often have very different responses to both diseases and treatments. So we're not yet sure which type of fluid is the most effective and safest for children with sepsis.

‘This trial aims to provide the answer.’

The trial

Australian and New Zealand sites are working with United States and Canadian emergency networks to undertake the trial. The National Institutes of Health is funding the United States arm of the study, the Canadian Institutes of Health Research is funding the Canadian arm, and MRFF is funding the Australian and New Zealand arm. The study will involve 8,800 children and is led by a team from Children's Hospital of Philadelphia.

‘The trial will enable us to determine the best fluid to use in children with sepsis,’ Professor Babl says. ‘The main measure will be to see whether there is a difference in the rates of renal impairment between normal saline and balanced fluid.

‘It’s also a tremendous opportunity to be part of a global project. The scale of the project means that we can also understand more about sepsis in children itself, including its epidemiology. This will set the stage for future studies both here and around the world.’

The trial involves 39 centres worldwide, with over 10 in Australia and New Zealand including:

  • The Royal Children’s Hospital, Murdoch Children’s Research Institute, University of Melbourne (Victoria) – the lead centre
  • Sydney Children’s Hospital (New South Wales)
  • The Children’s Hospital at Westmead (New South Wales)
  • Queensland Children’s Hospital (Queensland)
  • Gold Coast University Hospital (Queensland)
  • Women’s and Children’s Hospital (South Australia)
  • Monash Children’s Hospital (Victoria)
  • Perth Children’s Hospital (Western Australia)
  • Royal Darwin Hospital
  • Starship Children’s Hospital (New Zealand)
  • Kidz First Children’s Hospital (New Zealand).

‘This trial will run over 5 years,’ Professor Babl says.

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