Gastroenteritis AcuteNCT07610382
Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
An observational study of Gastroenteritis Acute and Dehydration, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Gastroenteritis Acute, Dehydration, Acidosis, Metabolic
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydin Adnan Menderes University Hospital, Department of Pediatric Emergency Care
Aydin, 09100
Aykut Çağlar, Proffesor, 05303337877, aykutcaglar@gmail.com
aykutcaglar@gmail.com
About this study
Official title: Comparison of Early Biochemical and Clinical Outcomes of Balanced Versus Unbalanced Isotonic Crystalloid in Children Aged 6 Months to 5 Years Who Require Intravenous Rehydration for Acute Gastroenteritis: A Single-Center Prospective Observational Cohort Study
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.
Read more
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.
Read the detailed description
BACKGROUND AND SCIENTIFIC RATIONALE Acute gastroenteritis causes gastrointestinal bicarbonate loss through diarrhoea, combined with reduced oral intake and, in severe cases, lactate accumulation from hypoperfusion, resulting in metabolic acidosis.
The conventional choice, 0.9% sodium chloride (NS), carries a supraphysiological chloride load (154 mEq/L versus plasma reference of 98-103 mEq/L). This reduces the strong ion difference (SID), independently precipitating hyperchloraemic metabolic acidosis and failing to correct pre-existing acidosis.
Isolyte-S has a chloride content of 98 mEq/L and contains acetate (27 mEq/L) and gluconate (23 mEq/L) as bicarbonate precursors. Acetate is rapidly metabolised in cardiac muscle, skeletal muscle, and renal cortex independently of hepatic function (half-life approximately 30 minutes) via: CH3COO- + O2 + H+ → 2CO2 + 2H2O, consuming 1 mEq of H+ per mEq of acetate. Gluconate undergoes hepatic oxidation via the pentose phosphate pathway with analogous H+ consumption. The total buffer capacity of Isolyte-S is 50 mEq/L - approximately twice that of Ringer's lactate (28 mEq/L). This active acid-neutralisation capacity is mechanistically distinct from simply avoiding chloride overload.
EVIDENCE BASE The 2023 Cochrane systematic review (Florez et al., 5 RCTs, 465 children) demonstrated improved bicarbonate and pH with balanced crystalloids but judged certainty as low to very low and explicitly called for new adequately powered studies. The meta-analysis by Lehr et al. (2022) reported a pooled delta-HCO3 of +1.60 mmol/L (95% CI 0.04-3.16) favouring balanced fluids in critically ill children. The only RCT using Plasma-Lyte A versus NS in paediatric AGE (Allen et al., 2016) reported delta-HCO3 of +1.6 versus 0.0 mEq/L at 4 hours (p=0.004) but was underpowered for clinical outcomes. No published study has investigated Isolyte-S (acetate/gluconate-buffered, 50 mEq/L total buffer capacity) specifically in children with AGE.
STUDY DESIGN Single-centre, prospective, non-interventional observational cohort study conducted in the paediatric emergency department of Aydin Adnan Menderes University Research and Training Hospital, Turkey (KAD-KLVZ-25). No randomisation, allocation, or investigator-initiated prescribing occurs. The treating physician's independent clinical decision determines group assignment before research consent and enrolment.
STATISTICAL FRAMEWORK
Sample size: 180 total enrolments (anticipated), yielding 126 evaluable participants assuming 70% T4 laboratory availability. Power calculation: minimum clinically important difference delta = 1.5 mmol/L, SD = 3.0 mmol/L, alpha = 0.05 (two-sided), power = 0.80.
Primary analysis: PS-IPTW (propensity score inverse probability of treatment weighting) combined with IPOW (inverse probability of observation weighting) to simultaneously address confounding by indication and informative T4 laboratory missingness. A pre-specified covariate list is fixed prior to data lock. Supporting analysis: multivariable linear regression with robust standard errors (HC3).
Pre-specified mechanistic mediation analysis: causal mediation framework (R package mediation) to partition the total effect on delta-HCO3 into the indirect effect mediated via delta-Cl (hyperchloraemic mechanism) and the direct effect attributable to acetate/gluconate buffering (ACME and ADE). This analysis is exploratory and will be reported as mechanism-consistent association, not causal inference. Seven pre-specified sensitivity analyses are defined in the statistical analysis plan.
Reporting standard: STROBE statement for observational studies. Software: R version 4.3 or later.
DATA COLLECTION Data are recorded on a standardised case report form at three time points: T0 (baseline, at IV fluid start), T4 (3-6 hour window, only if routine laboratory results are available), and 72 hours (electronic health record review for return visits). No study-mandated procedures, tests, or visits are added to the routine care pathway. T4 laboratory values are ascertained exclusively from blood gas or electrolyte results obtained during routine clinical management.
- Conditions
- Gastroenteritis Acute, Dehydration, Acidosis, Metabolic, Diarrhea, Vomiting
- Keywords
- balanced crystalloid, normal saline, bicarbonate, metabolic acidosis, pediatric emergency, Acute Gastroenteritis, Dehydration
- Medical subject headings
- Dehydration, Acidosis, Diarrhea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 4 hours (3-6 hour window) after IV fluid initiation
Secondary outcomes (7)
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.
Measured: 3-6 hours after IV fluid initiation
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.
Measured: 3-6 hours after IV fluid initiation
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.
Measured: 3-6 hours after IV fluid initiation
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.
Measured: Within 6 hours of IV fluid initiation
Time to First Tolerated Oral Intake
Time in hours from IV fluid initiation to first documented tolerated oral fluid intake. Censored at 24 hours or at hospital admission, whichever occurs first. Analysed using weighted Cox regression.
Measured: From IV fluid initiation until first tolerated oral intake, assessed up to 24 hours
Hospital Admission Decision
Binary outcome: whether the treating physician decided to admit the child (observation unit, ward, or ICU), as documented in the electronic health record.
Measured: From emergency department presentation until disposition decision, up to 24 hours
72-Hour Emergency Department Return Visit
Binary outcome: unplanned return to the emergency department within 72 hours of discharge, regardless of cause, as identified through electronic health record linkage.
Measured: Within 72 hours of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start15 May 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Çağlar, MD, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610382
- Sponsor's protocol ID
- ADUPEDFluid
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to Turkish personal health data protection regulations (KVKK). De-identified aggregate summary data will be made available upon reasonable request to the corresponding author following publication.
Publications
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.
PubMed 28933805Mahajan 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.
PubMed 22791671Kartha 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.
PubMed 28422812Antequera 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.
PubMed 31334842Fernandez 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.
PubMed 40500670Allen 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.
PubMed 27480410Lehr 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.
PubMed 34991134Florez 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.
PubMed 37196992
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Biochemical and Clinical Outcomes of Balanced Versus Unbalanced Isotonic Crystalloid in Children Aged 6 Months to 5 Years Who Require Intravenous Rehydration for Acute Gastroenteritis: A Single-Center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07610382
- Acronym / sponsor ID
- ADUPEDFluid
- Conditions
- Gastroenteritis Acute, Dehydration, Acidosis, Metabolic, Diarrhea, Vomiting
- Keywords
- balanced crystalloid, normal saline, bicarbonate, metabolic acidosis, pediatric emergency, Acute Gastroenteritis, Dehydration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND AND SCIENTIFIC RATIONALE Acute gastroenteritis causes gastrointestinal bicarbonate loss through diarrhoea, combined with reduced oral intake and, in severe cases, lactate accumulation from hypoperfusion, resulting in metabolic acidosis.
The conventional choice, 0.9% sodium chloride (NS), carries a supraphysiological chloride load (154 mEq/L versus plasma reference of 98-103 mEq/L). This reduces the strong ion difference (SID), independently precipitating hyperchloraemic metabolic acidosis and failing to correct pre-existing acidosis.
Isolyte-S has a chloride content of 98 mEq/L and contains acetate (27 mEq/L) and gluconate (23 mEq/L) as bicarbonate precursors. Acetate is rapidly metabolised in cardiac muscle, skeletal muscle, and renal cortex independently of hepatic function (half-life approximately 30 minutes) via: CH3COO- + O2 + H+ → 2CO2 + 2H2O, consuming 1 mEq of H+ per mEq of acetate. Gluconate undergoes hepatic oxidation via the pentose phosphate pathway with analogous H+ consumption. The total buffer capacity of Isolyte-S is 50 mEq/L - approximately twice that of Ringer's lactate (28 mEq/L). This active acid-neutralisation capacity is mechanistically distinct from simply avoiding chloride overload.
EVIDENCE BASE The 2023 Cochrane systematic review (Florez et al., 5 RCTs, 465 children) demonstrated improved bicarbonate and pH with balanced crystalloids but judged certainty as low to very low and explicitly called for new adequately powered studies. The meta-analysis by Lehr et al. (2022) reported a pooled delta-HCO3 of +1.60 mmol/L (95% CI 0.04-3.16) favouring balanced fluids in critically ill children. The only RCT using Plasma-Lyte A versus NS in paediatric AGE (Allen et al., 2016) reported delta-HCO3 of +1.6 versus 0.0 mEq/L at 4 hours (p=0.004) but was underpowered for clinical outcomes. No published study has investigated Isolyte-S (acetate/gluconate-buffered, 50 mEq/L total buffer capacity) specifically in children with AGE.
STUDY DESIGN Single-centre, prospective, non-interventional observational cohort study conducted in the paediatric emergency department of Aydin Adnan Menderes University Research and Training Hospital, Turkey (KAD-KLVZ-25). No randomisation, allocation, or investigator-initiated prescribing occurs. The treating physician's independent clinical decision determines group assignment before research consent and enrolment.
STATISTICAL FRAMEWORK
Sample size: 180 total enrolments (anticipated), yielding 126 evaluable participants assuming 70% T4 laboratory availability. Power calculation: minimum clinically important difference delta = 1.5 mmol/L, SD = 3.0 mmol/L, alpha = 0.05 (two-sided), power = 0.80.
Primary analysis: PS-IPTW (propensity score inverse probability of treatment weighting) combined with IPOW (inverse probability of observation weighting) to simultaneously address confounding by indication and informative T4 laboratory missingness. A pre-specified covariate list is fixed prior to data lock. Supporting analysis: multivariable linear regression with robust standard errors (HC3).
Pre-specified mechanistic mediation analysis: causal mediation framework (R package mediation) to partition the total effect on delta-HCO3 into the indirect effect mediated via delta-Cl (hyperchloraemic mechanism) and the direct effect attributable to acetate/gluconate buffering (ACME and ADE). This analysis is exploratory and will be reported as mechanism-consistent association, not causal inference. Seven pre-specified sensitivity analyses are defined in the statistical analysis plan.
Reporting standard: STROBE statement for observational studies. Software: R version 4.3 or later.
DATA COLLECTION Data are recorded on a standardised case report form at three time points: T0 (baseline, at IV fluid start), T4 (3-6 hour window, only if routine laboratory results are available), and 72 hours (electronic health record review for return visits). No study-mandated procedures, tests, or visits are added to the routine care pathway. T4 laboratory values are ascertained exclusively from blood gas or electrolyte results obtained during routine clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Serum Bicarbonate (Delta-HCO3)
Time frame: Approximately 4 hours (3-6 hour window) after IV fluid initiation
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.
7 secondary outcomes
Change in Blood pH (Delta-pH)
Time frame: 3-6 hours after IV fluid initiation
Change in Base Excess (Delta-BE)
Time frame: 3-6 hours after IV fluid initiation
Change in Serum Chloride (Delta-Cl)
Time frame: 3-6 hours after IV fluid initiation
Additional IV Fluid Bolus Requirement
Time frame: Within 6 hours of IV fluid initiation
Time to First Tolerated Oral Intake
Time frame: From IV fluid initiation until first tolerated oral intake, assessed up to 24 hours
Hospital Admission Decision
Time frame: From emergency department presentation until disposition decision, up to 24 hours
72-Hour Emergency Department Return Visit
Time frame: Within 72 hours of discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 28933805Bampoe 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.
- Background: PubMed 22791671Mahajan 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.
- Background: PubMed 28422812Kartha 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.
- Background: PubMed 31334842Antequera 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.
- Background: PubMed 40500670Fernandez 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.
- Background: PubMed 27480410Allen 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.
- Background: PubMed 34991134Lehr 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.
- Background: PubMed 37196992Florez 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.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to Turkish personal health data protection regulations (KVKK). De-identified aggregate summary data will be made available upon reasonable request to the corresponding author following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis Acute and Dehydration, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aykut Çağlar, Professor (+905303337877, aykutcaglar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Bicarbonate (Delta-HCO3) (time frame: Approximately 4 hours (3-6 hour window) after IV fluid initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07610382, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.