PICO: Population(s): Hospitalized patients > 28 days to 21 years of age Intervention(s): Isotonic (0.9% sodium chloride, 154 mEq/L) verses hypotonic maintenance parenteral fluids Comparator(s): Development of hospital-acquired or aggravated hyponatremia Outcomes(s): Prevention of hospital-acquired or aggravated hyponatremia

Has the standard approach of using hypotonic saline, e.g. 0.2% and 0.45% sodium chloride, in maintenance parenteral fluids, i.e. 1500 ml/m2/D, been associated with the development of hyponatremia ( sodium < 135 mEq/L) and neurological complications, such as death or permanent neurologic impairment, related to hyponatremic encephalopathy?

Is isotonic saline ( e.g.0.9% sodium chloride, 154 mEq/L and Lactated Ringer's solution, 130 mEq/L) superior to hypotonic saline solutions (sodium concentration < 130 mEq/L) in maintenance parenteral fluids for the prevention of hospital-acquired or aggravated hyponatremia in children > 28 days to 21 years of age?

The population includes hospitalized patients > 28 days to 21 years of age receiving maintenance intravenous fluids.

The subgroups of patients that this study will apply to are hospitalized patients with conditions that will limit their oral intake and necessitate the use of maintenance intravenous fluids. High risk groups that require maintenance intravenous fluids would include post-surgical patients, critically ill patients, and patients with dehydration, respiratory diseases, central nervous system infections and hydration for cancer chemotherapy.

Maintenance intravenous fluids are the corner stone to supportive care of the acutely-ill hospitalized child. The standard approach to maintenance fluid therapy for over fifty-years has been to administer hypotonic solutions, e.g. with a serum sodium concentration less than that of the plasma sodium. These recommendations were primarily based on the average needs for both sodium and water in the otherwise healthy child. These recommendations may not apply to the acutely-ill child who has numerous potential stimuli for antidiuretic hormone (ADH) secretion. ADH impairs the kidneys ability to excrete free water and excess ADH places hospitalized patients at risk for the development of hyponatremia from free water retention. Stimuli for ADH excretion in the acutely ill child includes hemodynamic stimuli such as dehydration and hypotension, and non-hemodynamic stimuli such as pain, stress, nausea, vomiting, medications such as narcotics, pulmonary disorders, central nervous disorders and the post-operative state, to name a few.

Extensive research in this topic in recent years has revealed that the incidence of hospital-acquired hyponatremia in children receiving hypotonic fluids is approximately 30%. The use of an isotonic fluid should reduce both the incidence of hyponatremia and hyponatremic encephalopathy. Children are at particularly high risk for developing hyponatremic encephalopathy due to a higher brain to skull size ratio in comparison to adults. There have been over 60 reports of death or permanent neurologic injury resulting from hospital-acquired hyponatremia in children. It has been proposed since 2002 that isotonic fluids be administered in maintenance parenteral fluids in order to prevent hospital-acquired hyponatremia in patients at risk for ADH excess. This approach generated significant controversy. There have since been over 20 studies in more than 3000 children demonstrating that hypotonic fluids result in hyponatremia and that isotonic fluids are safe and effective in decreasing the incidence of hospital-acquired hyponatremia. Patient safety organizations in the United Kingdom, Canada and the U.S. have thus issued warnings regarding the dangers of using hypotonic fluids. Recent surveys have demonstrated that hypotonic maintenance fluids are still primarily administered to children. Despite the extensive research on this topic, there is no evidence-based consensus on maintenance fluid therapy in children.

We are concerned that the current approach of using hypotonic saline solutions (sodium < 130 mEq/L) for maintenance parenteral therapy ( i.e. 1500 ml/m2/D) is associated with hospital-acquired or aggravated hyponatremia (sodium < 135 mEq/L). This can lead to hyponatremic encephalopathy ( i.e. nausea, vomiting, lethargy, decreased deep tendon reflexes, disorientation, seizures, coma, respiratory arrest) and result in death or permanent neurologic impairment.

We are interested in determining if the use of intravenous isotonic saline (sodium ? 154 mEq/L) would prevent the development of hospital-acquired or aggravated hyponatremia ( sodium < 135 mEq/L), and prevent neurological complications, such as death or permanent neurologic impairment, related to hyponatremia in comparison to the standard approach of using hypotonic maintenance parenteral fluids (sodium < 130 mEq/L).

If the evidence demonstrates that the use of hypotonic maintenance intravenous fluids is associated with the development of hyponatremia and neurological complications, such as death or permanent neurologic impairment, related to hyponatremic encephalopathy and that intravenous isotonic fluids decrease the incidence of hospital-acquired or aggravated hyponatremia in comparison to hypotonic fluids, then the American Academy of Pediatrics can provide recommendations to avoid the routine use of hypotonic intravenous fluids in disease states associated with ADH excess.

If the systematic review of the current literature demonstrates that the use of isotonic intravenous maintenance fluids is associated with decreased incidence of hyponatremia and neurological complications, such as death or permanent neurologic impairment, related to hyponatremic encephalopathy when compared with the common approach of using hypotonic fluids, then the American Academy of Pediatrics can provide evidence based recommendations to avoid the routine use of hypotonic intravenous fluids in disease states associated with ADH excess.

A clinical guideline and evidence based approach is needed within the year.

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