A randomised controlled trial of Plasmalyte148 with 5% dextrose compared to 0.45% sodium chloride with 5% dextrose for maintenance intravenous fluid therapy in hospitalised children.

When children are hospitalised, they often require fluid through an intravenous line (or “drip”). This is usually because they can’t eat or drink enough to stay hydrated. The fluid is made up of water, sugar and some salts. There is uncertainty regarding the ideal sodium concentration for fluid given through a drip. Sodium is a salt which is naturally contained in the body. However, when sodium levels in the body rise or fall suddenly, it is dangerous. In rare cases, this has led to brain damage and death. Currently, when children need intravenous fluid, they are usually given a fluid that contains about half the concentration of sodium that the blood in the body naturally contains. This fluid is called 0.45% sodium chloride. For most children, this doesn’t have a bad effect. However, in some sick children, this fluid “dilutes” the blood, causing the blood sodium level to drop quickly. This side effect is rare, but is potentially very serious. We believe that we can make the fluid safer by increasing the sodium concentration. This should make it less likely that the sodium level in the blood will drop suddenly. This, in turn, should reduce the number of children who have bad side effects. We will conduct a study that compares the fluid we currently use (0.45% sodium chloride) with a fluid that contains more sodium (Plasmalyte148). Plasmalyte148 contains approximately the same concentration of sodium as is naturally contained in the blood. This is approximately double the concentration of sodium when compared with 0.45% sodium chloride. Children at the Royal Children’s Hospital who require fluid through a drip will be asked to participate in the trial. They will be randomly allocated either to 0.45% sodium chloride or to Plasmalyte148. The participants will not know the type of fluid they receive, nor will their doctors. The participants will be monitored with regular blood tests. The children will stay in the study for three days, or until they no longer require most of their hydration through a drip. We will compare blood test results for the children in each group (the 0.45% sodium chloride group compared with the Plasmalyte148 group). We will determine whether Plasmalyte148 results in more normal blood sodium results when compared with the fluid we currently use.