A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis.
Coburn H Allen, Ran D Goldman, Seema Bhatt...
https://pubmed.ncbi.nlm.nih.gov/27480410/Actively Recruiting
Led by Aydin Adnan Menderes University · Updated on 2026-05-28
180
Participants Needed
1
Research Sites
8 weeks
Total Duration
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, childrens 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
Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
A
Aykut Çağlar, Professor
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Aydin Adnan Menderes University
Lead Sponsor
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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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor