Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Children who are undergoing surgery need intravenous fluids to prevent dehydration and
maintain their electrolyte balance. The current standard of care in these children is to use
a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been
tested. There is ongoing concern from the medical community that this type of fluid increases
the child's risk of developing low sodium levels, and hence may not be safe for all children.
Low sodium can lead to significant complications such as seizures, coma and even death, risks
of which are often underestimated and not anticipated by their caregivers. Experts in the
field suggest that giving a solution with a similar sodium content to that of blood (isotonic
fluid) reduces the risk of these problems in these children. This study will compare these
two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e.
neither the patient nor caregivers or investigators will be aware which type of fluid the
patient is receiving), in children following surgery. The investigators goal is to see which
type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a
lower risk of complications as described above.
This is the first time such a study is preformed in pediatrics. There are unnecessary number
of complications and potential deaths from this disorder, and hence the safety of everyday
fluid practice in children needs to be scientifically tested. The results of this study will
enable the investigators to propose scientifically based guidelines on how to minimize risks
associated with intravenous infusions in children.