Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis

NCT07610382 | Recruiting

• 1 other identifier: ADUPEDFluid
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis Acute; Dehydration; Acidosis, Metabolic; Diarrhea; Vomiting

Keywords

balanced crystalloid; normal saline; bicarbonate; metabolic acidosis; pediatric emergency; Acute Gastroenteritis; Dehydration

Outcome Measures

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.

  Approximately 4 hours (3-6 hour window) after IV fluid initiation

Secondary Outcomes (7)

• Change in Blood pH (Delta-pH)

  3-6 hours after IV fluid initiation

• Change in Base Excess (Delta-BE)

  3-6 hours after IV fluid initiation

• Change in Serum Chloride (Delta-Cl)

  3-6 hours after IV fluid initiation

• Additional IV Fluid Bolus Requirement

  Within 6 hours of IV fluid initiation

• Time to First Tolerated Oral Intake

  From IV fluid initiation until first tolerated oral intake, assessed up to 24 hours

Study Arms (2)

0.9% Sodium Chloride

Children with acute gastroenteritis who received 0.9% sodium chloride (Na+ 154, Cl- 154 mEq/L) as the initial IV crystalloid, as independently selected by the treating physician. No research-directed intervention.

Balanced Crystalloid (Isolyte-S)

Children with acute gastroenteritis who received an acetate/gluconate-buffered balanced isotonic crystalloid (Isolyte-S: Na+ 141, K+ 5, Mg2+ 3, Cl- 98, acetate 27, gluconate 23 mEq/L) as the initial IV crystalloid, as independently selected by the treating physician. No research-directed intervention.

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University Hospital, Department of Pediatric Emergency Care

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Bampoe S, Odor PM, Dushianthan A, Bennett-Guerrero E, Cro S, Gan TJ, Grocott MP, James MF, Mythen MG, O'Malley CM, Roche AM, Rowan K, Burdett E. Perioperative administration of buffered versus non-buffered crystalloid intravenous fluid to improve outcomes following adult surgical procedures. Cochrane Database Syst Rev. 2017 Sep 21;9(9):CD004089. doi: 10.1002/14651858.CD004089.pub3.

  PMID: 28933805 BACKGROUND

• Mahajan V, Sajan SS, Sharma A, Kaur J. Ringers lactate vs Normal saline for children with acute diarrhea and severe dehydration- a double blind randomized controlled trial. Indian Pediatr. 2012 Dec;49(12):963-8. doi: 10.1007/s13312-012-0251-x. Epub 2012 Mar 30.

  PMID: 22791671 BACKGROUND

• Kartha GB, Rameshkumar R, Mahadevan S. Randomized Double-blind Trial of Ringer Lactate Versus Normal Saline in Pediatric Acute Severe Diarrheal Dehydration. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):621-626. doi: 10.1097/MPG.0000000000001609.

  PMID: 28422812 BACKGROUND

• Antequera Martin AM, Barea Mendoza JA, Muriel A, Saez I, Chico-Fernandez M, Estrada-Lorenzo JM, Plana MN. Buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children. Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD012247. doi: 10.1002/14651858.CD012247.pub2.

  PMID: 31334842 BACKGROUND

• Fernandez Montes R, Alonso Alvarez MA, Fernandez Miaja M, Vega Lopez L, Alvarez Merino M, Garrido Garcia E. Plasmalyte versus saline solution for rapid rehydration in gastroenteritis: prospective observational study. An Pediatr (Engl Ed). 2025 Jun;102(6):503855. doi: 10.1016/j.anpede.2025.503855. Epub 2025 Jun 10.

  PMID: 40500670 BACKGROUND

• Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.

  PMID: 27480410 BACKGROUND

• Lehr AR, Rached-d'Astous S, Barrowman N, Tsampalieros A, Parker M, McIntyre L, Sampson M, Menon K. Balanced Versus Unbalanced Fluid in Critically Ill Children: Systematic Review and Meta-Analysis. Pediatr Crit Care Med. 2022 Mar 1;23(3):181-191. doi: 10.1097/PCC.0000000000002890.

  PMID: 34991134 BACKGROUND

• Florez ID, Sierra J, Perez-Gaxiola G. Balanced crystalloid solutions versus 0.9% saline for treating acute diarrhoea and severe dehydration in children. Cochrane Database Syst Rev. 2023 May 17;5(5):CD013640. doi: 10.1002/14651858.CD013640.pub2.

  PMID: 37196992 BACKGROUND

MeSH Terms

Conditions

Dehydration; Acidosis; Diarrhea; Vomiting

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

Aykut Çağlar, Professor

CONTACT

+905303337877; aykutcaglar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 28, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)