What is sepsis?

Sepsis is a medical emergency caused by infection. Sepsis is the most expensive hospital condition in North America and for critically ill children it is the most common cause of hospital death. In Canada, approximately 4000 children are hospitalized annually for sepsis with a median hospital length of stay of 12 days.

How do we treat sepsis?

Children who have developed sepsis need urgent care in the Emergency Department (ED) and may require specialized equipment such as ventilators for support. In addition to stabilizing vital signs (e.g. breathing rate, blood pressure, body temperature), doctors treat sepsis with intravenous (IV) fluids, antibiotics, and other medications as needed. Two types of IV fluids are commonly used in EDs for treating children with sepsis: balanced fluids (BF) and “normal” saline (NS).

Why are we doing this study?

There is currently no research that clearly shows which IV fluid is the most effective and safest to use. The purpose of this study is to compare the effectiveness and safety of the two types of IV fluid (BF versus NS) to improve clinical outcomes in children treated for sepsis.

Who is doing this study?

Thirteen pediatric EDs across Canada are partnering with hospitals in the United States, Australia, and New Zealand to enroll approximately 8,800 children worldwide. We estimate that 350 children will take part in this study at the Alberta Children’s Hospital.

How will this study work?

Children who have sepsis and are eligible for the study will be randomly assigned to receive BF or NS for all of their IV needs. The fluids will be given until midnight the day after the children started in the study. The type of IV fluid (BF or NS) will be the only thing affected by participation in this study. Any decisions about how much or how often the IV fluid is given, as well as any other medications or procedures, will be determined by the treating physician and health care team as they normally would do for any other child with sepsis.

What is deferred consent?

The Canadian Institute of Health Research, through the Tri-Council Policy Statement on Ethic Research involving Humans, has created a set of special rules for clinical trials in critically ill patients who require emergent treatment when true prospective informed consent is not possible or may put the patient at risk for increased harm due to delays in life-saving therapies.

Because sepsis is considered a life-threatening illness, this study has been approved by the Conjoint Health Research Ethics Board of the University of Calgary to proceed with deferred consent. Children who are eligible for the study will be enrolled while life-saving treatment is provided, and a member of the research team will speak with the family to obtain consent to continue in the study at a mutually beneficial time.