Acute Gastroenteritis, Dehydration
Conditions
Keywords
vomiting, diarrhea
Brief summary
To compare length of stay (LOS) of pediatric patients in a pediatric emergency room presenting with Gastroenteritis treated with IV rehydration versus oral Speedlyte rehydration.
Detailed description
Gastroenteritis leading to dehydration is very commonly encountered in the pediatric emergency room setting. Oral rehydration therapy (ORT) is the first line therapy recommended by the American Academy of Pediatrics but is seldom used compared to intravenous therapy (IVT). ORT has many advantages including less traumatic to the patient, can be administered by mouth, can be administered at home and less costly compared to IVT. Furthermore, intravenous fluids may present several complications with IV placement such as infiltration, hematoma, air embolism, phlebitis, extravascular injection, intraarterial injection, etc. Speedlyte is a new oral rehydration product with lipophilic absorption which allows for electrolytes to be more readily absorbed compared to other oral rehydration solutions. The liposome encapsulates the salty molecules which is thought to decrease the negative salty taste associated with oral rehydration solutions. In addition, the encapsulation of electrolytes allows for more molecules to be delivered past the stomach acids and absorbed into the body under higher bioavailability due to the lipid shell. Participants will be randomized into two rehydration groups. One group will receive oral rehydration with the Speedlyte product, the amount will be based on the participant's weight. The other group will receive intravenous rehydration with a normal saline bolus per physician practice, usually in the amount of 20 mL/kg. These interventions can be incorporated into the emergency room practice without undue expense to the setting or placing excessive demands on nursing time as these practices are standard of care in many rehydration cases.
Interventions
OTHERStandard IV Rehydration Therapy
IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)
Speedlyte oral solution as rehydration therapy based on participant's weight (10 m/l kg over one hour). Total of 150 ml/kg over 24 hours prior to discharge
Sponsors
Einsoff Biohealth
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The assignment of treatment will be concealed from research team members involved in recruiting patients by using sealed, sequentially numbered, opaque envelopes containing the type of rehydration treatment to be used.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 6 mths to 18 years; * Signs and symptoms of dehydration for less than a week * Diagnosis of acute gastroenteritis, dehydration, vomiting, and/or diarrhea; * Patient able to drink from bottle and/or cup; * Per clinician's judgment, patient needs rehydration with IV solution.
Exclusion criteria
* Chronic disease that includes but not limited to TB, HIV, congenital heart disease with hemodynamic consequences, metabolic disease, cerebral palsy, adrenal hyperplasia, renal tubular acidosis, and nephropathy; * Vomiting due to head trauma; * Severe hydration; * Diabetic ketoacidosis; * Bloody diarrhea; * Diarrhea for more than a week; * Malnutrition; * Burns; * Pneumonia; * Meningitis; * History of seizures; * Absent bowel sounds; * Not able to drink from bottle or cup; * Previous allergic reaction to citrate or other food coloring particles/formulation; * Parent/legal guardian refusing to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (LOS) | up to 24 hours | Comparison of length of stay (LOS) in a pediatric emergency department in the treatment of acute gastroenteritis between the oral rehydration solution Speedlyte and intravenous rehydration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjunct Medication | up to 24 hours | Number of adjunct medications given in the ED in both groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to initiation of therapy | up to 24 hours | Time to initiation of therapy in each group |
| Number of patients that fail to rehydrate | up to 24 hours | Obtain the number of patients that fail to rehydrate in each group. Oral requiring IV intervention, IV requiring further fluids and/or admission. |
| Hospitalization rate | up to 24 hours | The rate of hospitalization for each group |
| Revisit rate in each group. | up to 24 hours | The revisit rate for each group |
Countries
United States
Outcome results
None listed