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IV Glucose for Dehydration Treatment

Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01285713
Enrollment
83
Registered
2011-01-28
Start date
2010-09-30
Completion date
2012-03-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration

Keywords

Dehydration, Gastroenteritis, Dehydration in Gastroenteritis

Brief 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.

Interventions

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

Sponsors

American Academy of Pediatrics
CollaboratorOTHER
Academic Pediatric Association
CollaboratorINDUSTRY
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
Yes

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, 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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis4 hoursMeasurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.

Countries

United States

Participant flow

Participants by arm

ArmCount
D5Normal Saline
10cc/kg D5NS, followed by 30cc/kg NS
42
Normal Saline
10cc/kg NS, followed by 30cc/kg NS
41
Total83

Baseline characteristics

CharacteristicNormal SalineD5Normal SalineTotal
Age, Categorical
<=18 years
41 Participants42 Participants83 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous3.4 years
STANDARD_DEVIATION 3
3.6 years
STANDARD_DEVIATION 3.3
3.5 years
STANDARD_DEVIATION 3.1
Region of Enrollment
United States
41 participants42 participants83 participants
Sex: Female, Male
Female
24 Participants22 Participants46 Participants
Sex: Female, Male
Male
17 Participants20 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 410 / 42
serious
Total, serious adverse events
0 / 410 / 42

Outcome results

Primary

Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis

Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.

Time frame: 4 hours

ArmMeasureValue (MEAN)Dispersion
D5Normal SalineMeasurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis1.10 mmol/LStandard Deviation 1.2
Normal SalineMeasurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis2.39 mmol/LStandard Deviation 1.62
p-value: 0.0003Paired t-test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026