IV Glucose for Dehydration Treatment

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01285713
• Collaborator: American Academy of Pediatrics (Other), Academic Pediatric Association (Industry)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 4.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dehydration	Drug: 5% Dextrose (D5) in Normal Saline (NS); Drug: Normal Saline (NS)	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5% Dextrose (D5) in Normal Saline (NS) 10cc/kg D5NS, followed by 30cc/kg NS	Drug: 5% Dextrose (D5) in Normal Saline (NS); D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS; Other Names: D5NS
Active Comparator: Normal Saline (NS) 10cc/kg NS, followed by 30cc/kg NS	Drug: Normal Saline (NS); NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS; Other Names: NS

Outcome Measures

Primary Outcome Measures

1. Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis [4 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 12 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia
• American Academy of Pediatrics
• Academic Pediatric Association

Investigators

• Principal Investigator: Elizabeth R Alpern, MD, Children's Hospital of Philadelphia
• Principal Investigator: Kari Posner, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT01285713
• Other Study ID Numbers: 10-007632
• First Posted: Jan 28, 2011
• Last Update Posted: Mar 19, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Children's Hospital of Philadelphia: Dehydration; Gastroenteritis; Dehydration in Gastroenteritis
• Additional relevant MeSH terms: Dehydration

Study Results

Participant Flow

Arm/Group Title	5% Dextrose (D5) in Normal Saline (NS)	Normal Saline (NS)
Arm/Group Description	10cc/kg 5% Dextrose (D5) in Normal Saline (NS) (D5NS), followed by 30cc/kg Normal Saline (NS)	10cc/kg NS, followed by 30cc/kg NS
Period Title: Overall Study
STARTED	42	41
COMPLETED	42	41
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	D5Normal Saline	Normal Saline	Total
Arm/Group Description	10cc/kg D5NS, followed by 30cc/kg NS	10cc/kg NS, followed by 30cc/kg NS	Total of all reporting groups
Overall Participants	42	41	83
Age (Count of Participants)
<=18 years	42 100%	41 100%	83 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.6 (3.3)	3.4 (3.0)	3.5 (3.1)
Sex: Female, Male (Count of Participants)
Female	22 52.4%	24 58.5%	46 55.4%
Male	20 47.6%	17 41.5%	37 44.6%
Region of Enrollment (participants) [Number]
United States	42 100%	41 100%	83 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D5Normal Saline	Normal Saline
Arm/Group Description	10cc/kg D5NS, followed by 30cc/kg NS	10cc/kg NS, followed by 30cc/kg NS
Measure Participants	33	36
Mean (Standard Deviation) [mmol/L]	1.10 (1.20)	2.39 (1.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	D5Normal Saline, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Paired t-test
	Comments

Adverse Events

Arm/Group Title	D5Normal Saline		Normal Saline
Arm/Group Description	10cc/kg D5NS, followed by 30cc/kg NS		10cc/kg NS, followed by 30cc/kg NS
All Cause Mortality
	D5Normal Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	D5Normal Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	D5Normal Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)

Limitations/Caveats

Single center study Small sample size Enrollment available 16 hours/day Evaluated one dextrose load of 500mg/kg

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.