Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-5
SponsorAydin Adnan Menderes University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Consecutive eligible children aged 6 months to 5 years presenting to the paediatric emergency department of Aydin Adnan Menderes University Hospital with acute gastroenteritis and a clinician-initiated indication for intravenous rehydration. Enrolment is prospective and observational; the treating physician independently determines IV fluid type and dose based on clinical judgment, without involvement from the research team.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 2 trial groupsGroup A: 0.9% Sodium Chloride
Group B: Balanced Crystalloid (Isolyte-S)
Trial outcomes
Primary outcomes
1
Change in Serum Bicarbonate (Delta-HCO3)
Change from baseline in serum bicarbonate concentration (mmol/L) at approximately 4 hours after IV fluid initiation. Defined as HCO3(T4) minus HCO3(T0), where T4 is the routine blood gas or electrolyte measurement obtained 3 to 6 hours after IV fluid start. Analysis performed only in participants for whom T4 laboratory results are available as part of routine clinical care. No additional blood sampling is performed for research purposes.
Time frame
Approximately 4 hours (3-6 hour window) after IV fluid initiationSecondary outcomes
1
Change in Blood pH (Delta-pH)
Change from baseline in arterial or capillary blood pH at approximately 4 hours. Calculated as pH(T4) minus pH(T0). Obtained from routine blood gas analysis only.
Time frame
3-6 hours after IV fluid initiation2
Change in Base Excess (Delta-BE)
Change from baseline in base excess (mmol/L) at approximately 4 hours. Calculated as BE(T4) minus BE(T0). Obtained from routine blood gas analysis only.
Time frame
3-6 hours after IV fluid initiation3
Change in Serum Chloride (Delta-Cl)
Change from baseline in serum chloride (mEq/L) at approximately 4 hours. Calculated as Cl(T4) minus Cl(T0). Serves as the mediator variable in the pre-specified causal mediation analysis.
Time frame
3-6 hours after IV fluid initiation4
Additional IV Fluid Bolus Requirement
Binary outcome: whether the treating physician administered one or more additional IV fluid boluses within 6 hours of initial IV fluid start, as documented in the routine clinical record.
Time frame
Within 6 hours of IV fluid initiationSponsors and contacts
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Source ClinicalTrials.gov