Actively Recruiting
Comparison of Early Biochemical and Clinical Outcomes of Balanced Versus Unbalanced Isotonic Crystalloid in Children Aged 6 Months to 5 Years Who Require Intravenous Rehydration for Acute Gastroenteritis
Led by Aydin Adnan Menderes University · Updated on 2026-05-28
180
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 6 months to 5 years who have acute gastroenteritis, a common cause of dehydration and emergency visits. The study compares two types of intravenous fluids used for rehydration: normal saline, which has a high chloride content, and balanced crystalloids like Isolyte-S, which contain acetate and gluconate to help neutralize acid. The goal is to see if balanced fluids improve blood bicarbonate levels and other clinical outcomes compared to normal saline. The study observes children who receive either normal saline or the balanced crystalloid Isolyte-S as part of their routine care, with the treating physician deciding which fluid to use independently. No additional tests or treatments are given for research purposes. Data are collected at baseline when fluids start, about 4 hours later from routine blood tests, and 72 hours after discharge to check for return visits. During participation, children's blood tests taken as part of standard care are reviewed to evaluate changes in serum bicarbonate, blood pH, chloride levels, and other measures like time to first oral intake and hospital admission. Researchers also track if additional IV fluid boluses are needed and monitor for emergency return visits within 72 hours. The study lasts through these observation points without extra procedures beyond usual care.
CONDITIONS
Brief Title
Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 months and 5 years inclusive
- Clinical diagnosis of acute gastroenteritis with acute diarrhoea (3 or more loose stools per 24 hours) with or without vomiting
- Symptoms lasting 7 days or less
- Doctor has independently decided intravenous rehydration is needed
- IV fluid treatment has been started and ordered by the treating physician independently from the research team
You will not qualify if you...
- Chronic systemic diseases such as congenital heart disease, chronic kidney disease, chronic lung disease, inborn errors of metabolism, or primary immunodeficiency
- High sodium levels in blood (serum sodium 150 mEq/L or higher) at baseline
- Diabetic ketoacidosis, primary metabolic crisis, or suspected surgical abdomen
- Bloody diarrhoea or suspected invasive enteric infection needing different management
- Low blood sugar level (below 60 mg/dL) at presentation
- Symptoms lasting longer than 7 days
- Received 20 mL/kg or more of intravenous fluid in the 24 hours before enrolment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours
Participants who receive intravenous fluids for acute gastroenteritis are observed during routine clinical care without any study-mandated interventions or procedures.
Routine clinical assessments during initial treatment and up to 24 hours
Duration - 72 hours after discharge
Participants are followed via electronic health records for any emergency department return visits within 72 hours after discharge.
1 follow-up review via electronic health record
Trial Site Locations
Total: 1 location
1
Aydin Adnan Menderes University Hospital, Department of Pediatric Emergency Care
Aydin, Turkey (Türkiye), 09100
Actively Recruiting
Research Team
A
Aykut Çağlar, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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