IV Glucose for Dehydration Treatment
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether the addition of dextrose to IV fluids in the treatment of
      gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of
      dextrose containing fluids in the treatment of gastroenteritis will be assessed.
    

Detailed description: 
      Background: Evaluation and treatment of dehydration in gastroenteritis is a cornerstone of
      pediatric emergency medicine, however there are no standard regimens or guidelines for the
      amount or type of fluids administered when a child requires intravenous hydration. Reduced
      carbohydrate intake in gastroenteritis leads to free fatty acid breakdown, excess ketones,
      and an increased likelihood for continued nausea and vomiting. Glucose therapy can treat this
      catabolic metabolism, improving the ability to overcome dehydration and starvation, and
      facilitate a child's return to baseline. There has been no previous randomized controlled
      study examining the utility of early intravenous dextrose in the treatment of
      gastroenteritis.

      Objectives: To determine whether the addition of dextrose to IV fluids in the treatment of
      gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of
      dextrose containing fluids in the treatment of gastroenteritis will be assessed.

      Methods: This is a double blinded randomized controlled trial of children between the ages of
      2 months and 12 years presenting to the Children's Hospital of Philadelphia (CHOP) Emergency
      Department (ED) who have gastroenteritis diagnosed by the ED attending or fellow and require
      intravenous hydration. Subjects will be randomized to either receive intravenous fluids
      containing dextrose or intravenous fluids without dextrose. The primary outcome measure is
      change in serum ketones during the intervention. Secondary outcomes are assessment of the
      clinical benefits of dextrose containing fluids in terms of persistence of emesis,
      satisfaction after treatment (physician and parental survey), admission rates, revisits
      within 1 week to the emergency department or to primary care physician, length of illness and
      parental assessment of time to return to baseline.

      Implications: Despite our current standard of using normal saline for intravenous
      rehydration, there is a high admission rate with lengthy stays in the emergency department
      for children with gastroenteritis. There is room for improvement in the treatment of a very
      common emergency department entity. It is hypothesized that glucose load and subsequent
      increased endogenous insulin production will reduce free fatty acid breakdown and facilitate
      faster resolution of ketosis, and thus quicker return to baseline. By measuring serum ketones
      before and after intravenous fluid administration with either glucose or standard normal
      saline, we can directly measure these effects.

      Inclusion Criteria

        1. Males or females age 2 months to 12th birth date

        2. Gastroenteritis (as diagnosed by ED attending or fellow physician)

        3. Need for IV fluids

        4. Dextrose stick of greater than 60 and less than 170

        5. Parental/guardian English speaking and granting informed consent

      Exclusion Criteria

        1. Underlying chronic disease affecting glucose metabolism or reason/persistence of
           symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder,
           ventriculoperitoneal (VP) shunt, Migraine Headaches

        2. Shock

        3. Vomiting greater than 72 hours since onset of illness

        4. Patients that have received IV fluids at an outside institution within 12 hours

      Investigational Plan: All enrolled subjects will have 1.5 microliters of blood collected onto
      a test strip during the IV placement performed for clinical care, and serum ketones will be
      measured using a bedside ketone meter. The ketone meter has been validated with comparison to
      standard laboratory beta-hydroxybutyrate levels (r=.92, p<0.0001). All patients will have a
      dehydration score recorded (Table 1). Subjects will be randomized to either the glucose
      containing IVF group or the non-glucose containing IVF group. All fluids will be prepared by
      a pharmacy and will be blinded to the treating team and patient. Those in the glucose
      containing IVF group will receive 10 cubic centimeter (cc) per kilogram (kg) (cc/kg) of
      5%Dextrose (D5) in normal saline (NS)(D5NS) and then an 30 cc/kg bolus of normal saline.
      Those randomized to the non-glucose containing IVF group will receive 10 cc/kg of normal
      saline and then the rest of the normal saline bolus (30cc/kg). Both study arms will have the
      fluid intervention they initially received repeated once with the goal of a total of 40cc/kg
      to be completed within 60 minutes. D5NS was chosen to decrease the exposure to free water
      while suppressing lipolysis. After the intervention is complete, serum ketones will again be
      measured by bedside meter and recorded for all subjects. The treating team is blinded to the
      ketone measurements. A dextrose stick will be obtained with the final ketone measurement, and
      if the value is >200, the treating team will be notified to ensure proper safety. Subjects
      will not be allowed to have oral intake during this 60 minute study period in order to allow
      for determination of effect of intervention. A repeat dehydration score is obtained at time
      of disposition.
    

Intervention name(s): 5% Dextrose (D5) in Normal Saline (NS); Normal Saline (NS)
Intervention type(s): Drug; Drug
Intervention description(s): D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS; NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS
Other intervention name(s): D5NS; NS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dehydration; Gastroenteritis; Dehydration in Gastroenteritis