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Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis

Recruitingn/aAges 6 Months - 5 YearsAllAydin Adnan Menderes University
NCT07610382 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Aydin Adnan Menderes University Hospital, Department of Pediatric Emergency Care
Aydin, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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