IV Glucose for Dehydration Treatment

NCT ID: NCT01285713

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

5% Dextrose (D5) in Normal Saline (NS)

10cc/kg D5NS, followed by 30cc/kg NS

Group Type: EXPERIMENTAL

5% Dextrose (D5) in Normal Saline (NS)

Intervention Type: DRUG

D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS

Normal Saline (NS)

10cc/kg NS, followed by 30cc/kg NS

Group Type: ACTIVE_COMPARATOR

Normal Saline (NS)

Intervention Type: DRUG

NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS

Interventions

5% Dextrose (D5) in Normal Saline (NS)

D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS

Intervention Type: DRUG

Normal Saline (NS)

NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS

Intervention Type: DRUG

Other Intervention Names

D5NS; NS

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Academic Pediatric Association

INDUSTRY

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth R Alpern, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Kari Posner, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

10-007632

Identifier Type: -

Identifier Source: org_study_id