IV Glucose for Dehydration Treatment
Primary Purpose
Dehydration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5% Dextrose (D5) in Normal Saline (NS)
Normal Saline (NS)
Sponsored by
About this trial
This is an interventional treatment trial for Dehydration focused on measuring Dehydration, Gastroenteritis, Dehydration in Gastroenteritis
Eligibility Criteria
Inclusion Criteria:
- Males or females age 2 months to 12th birth date
- Gastroenteritis (as diagnosed by ED attending or fellow physician)
- Need for IV fluids
- Dextrose stick of greater than 60 and less than 170
- Parental/guardian English speaking and granting informed consent
Exclusion Criteria:
- Underlying chronic disease affecting glucose metabolism or reason/persistence of symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder, VP shunt, Migraine Headaches
- Shock
- Vomiting greater than 72 hours since onset of illness
- Patients that have received IV fluids at an outside institution within 12 hours
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5% Dextrose (D5) in Normal Saline (NS)
Normal Saline (NS)
Arm Description
10cc/kg D5NS, followed by 30cc/kg NS
10cc/kg NS, followed by 30cc/kg NS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01285713
First Posted
January 27, 2011
Last Updated
February 26, 2019
Sponsor
Children's Hospital of Philadelphia
Collaborators
American Academy of Pediatrics, Academic Pediatric Association
1. Study Identification
Unique Protocol Identification Number
NCT01285713
Brief Title
IV Glucose for Dehydration Treatment
Official Title
Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
American Academy of Pediatrics, Academic Pediatric Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Males or females age 2 months to 12th birth date
Gastroenteritis (as diagnosed by ED attending or fellow physician)
Need for IV fluids
Dextrose stick of greater than 60 and less than 170
Parental/guardian English speaking and granting informed consent
Exclusion Criteria
Underlying chronic disease affecting glucose metabolism or reason/persistence of symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder, ventriculoperitoneal (VP) shunt, Migraine Headaches
Shock
Vomiting greater than 72 hours since onset of illness
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
Dehydration, Gastroenteritis, Dehydration in Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5% Dextrose (D5) in Normal Saline (NS)
Arm Type
Experimental
Arm Description
10cc/kg D5NS, followed by 30cc/kg NS
Arm Title
Normal Saline (NS)
Arm Type
Active Comparator
Arm Description
10cc/kg NS, followed by 30cc/kg NS
Intervention Type
Drug
Intervention Name(s)
5% Dextrose (D5) in Normal Saline (NS)
Other Intervention Name(s)
D5NS
Intervention Description
D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS
Intervention Type
Drug
Intervention Name(s)
Normal Saline (NS)
Other Intervention Name(s)
NS
Intervention Description
NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS
Primary Outcome Measure Information:
Title
Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males or females age 2 months to 12th birth date
Gastroenteritis (as diagnosed by ED attending or fellow physician)
Need for IV fluids
Dextrose stick of greater than 60 and less than 170
Parental/guardian English speaking and granting informed consent
Exclusion Criteria:
Underlying chronic disease affecting glucose metabolism or reason/persistence of symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder, VP shunt, Migraine Headaches
Shock
Vomiting greater than 72 hours since onset of illness
Patients that have received IV fluids at an outside institution within 12 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Alpern, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kari Posner, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IV Glucose for Dehydration Treatment
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