Watch this video to learn more about the study:
What is sepsis?
Sepsis is a potentially life threatening response to infection that
- Can happen to someone of any age
- Can cause damage to many of the body’s organs
- Can prevent a person from being able to function normally or independently
- Can limit awareness and cause coma
- Can cause death
How is sepsis treated?
Sepsis is treated with emergency therapies that include antibiotics and fluids, usually given through an IV. The most common place for sepsis to be treated when it occurs in the community is in an emergency department (ED) followed by admission to hospital for ongoing treatment.
How will the study work?
If a child is enrolled in PRoMPT BOLUS, they will be randomly assigned during their ED visit (like the flip of a coin) to receive either 0.9% saline or balanced fluids as part of their sepsis treatment. They will then receive study fluid as their treatment fluid during the remainder of their ED visit and for up to 48 hours of their hospitalisation if they are admitted to the hospital. The child’s doctors will determine when to give fluid and how much fluid to give, just as they would for a child not in the study.
What is the difference between 0.9% saline and balanced fluids?
Both 0.9% saline and balanced fluids like Plasma-Lyte 148, Ringer’s Lactate, and Hartmann’s Solution are electrolyte solutions- forms of salt water- that are safe and commonly used to treat sepsis. Both 0.9% saline and balanced fluids are used to treat children with sepsis in the Paediatric Intensive Care Unit. The chemical composition of 0.9% saline and balanced fluids are slightly different in that 0.9% saline has only sodium and chloride, while balanced fluids contains less sodium, less chloride, and also have small amounts of other electrolytes like calcium and potassium.
Why is this study being done?
Although both 0.9% saline and balanced fluids are safe and commonly used to treat sepsis, nobody knows for sure whether one fluid is more effective and safer to treat sepsis than the other. Several prior studies have suggested that balanced fluids may be superior to 0.9% saline, but a clear determination cannot be made without a large clinical trial. In paediatrics, 0.9% saline is generally the preferred fluid used to treat sepsis but balanced fluids are also commonly used, especially for children in Paediatric Intensive Care Units (PICU). However, nobody yet knows for sure which fluid is safer or more effective.
What are the risks of study participation?
Because both fluid types are effective, safe, and recommended for treatment of sepsis, all children in this study will receive standard care, regardless of which fluid is given. But because, as part of this study, your child will be randomly assigned (like a “flip of a coin”) to receive either 0.9% saline or balanced fluids rather than your doctor selecting which fluid to give your child, your child may receive a fluid that you might not have otherwise received. If there are differences in effectiveness and safety between these two fluids, then length of stay in hospital or other outcomes may be different depending on the fluid you receive and one fluid may have higher mortality than the other.
Will the study affect any other part of a child’s treatment for sepsis?
No. Decisions about when and how much fluid a child receives, as well as any other medications that they might need will not be affected by the study. These will be decided by the treatment team as they normally would for any child with possible sepsis.
What if my child is enrolled in the study and I change my mind about wanting them to participate?
A parent or patient is free to withdraw from study participation at any time by contacting the study team.