NCT07610382 Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 180 participants in total. It began in 2026-05-15 with a primary completion date of 2027-01.

Brief Summary

Acute gastroenteritis (AGE) is among the most common reasons for paediatric emergency visits. Children with significant dehydration often require intravenous (IV) fluid therapy. Two main types of IV crystalloid solutions are currently used in clinical practice: 0.9% sodium chloride (normal saline, NS) and balanced crystalloids such as Isolyte-S, which contain acetate and gluconate as bicarbonate precursors. Normal saline has a high chloride content (154 mEq/L), which may worsen the metabolic acidosis already present in many children with acute gastroenteritis. Balanced crystalloids have a chloride content closer to that of plasma (98 mEq/L) and additionally contain acetate and gluconate, which are metabolised in peripheral tissues to consume hydrogen ions and thereby raise serum bicarbonate - a mechanism distinct from simply avoiding chloride overload. This study prospectively observes and compares early biochemical and clinical outcomes in children with acute gastroenteritis who receive one of these two fluid types as part of their routine clinical care. The treating physician independently decides which fluid to use; the research team does not influence this decision and does not order any additional tests or procedures. Laboratory values used as outcomes are drawn solely from blood tests obtained as part of standard care. The primary aim is to determine whether, at approximately 4 hours after IV fluid start, serum bicarbonate has changed more in children who received a balanced crystalloid compared with those who received normal saline. Secondary aims include comparing blood pH, chloride levels, need for additional IV boluses, time to first oral fluid intake, hospitalisation rate, and 72-hour return visits.

Eligibility Criteria

Inclusion Criteria: * Age: 6 months to 5 years (60 months) inclusive * Clinical diagnosis of acute gastroenteritis: acute diarrhoea (3 or more loose stools per 24 hours) with or without vomiting; symptom duration 7 days or less * Clinician-initiated indication for intravenous rehydration * IV fluid order placed and treatment initiated independently by the treating physician, without research team influence Exclusion Criteria: * Chronic systemic disease (congenital heart disease, chronic kidney disease, chronic lung disease, inborn errors of metabolism, primary immunodeficiency) * Hypernatraemic dehydration (serum sodium \>= 150 mEq/L at baseline) * Diabetic ketoacidosis, primary metabolic crisis, or suspected surgical abdomen * Bloody diarrhoea or suspected invasive enteric infection requiring alternative management algorithm * Hypoglycaemia (blood glucose \< 60 mg/dL) at presentation * Symptom duration exceeding 7 days * Receipt of 20 mL/kg or more of IV fluid in the 24 hours preceding enrolment

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