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Comparing balanced fluid and normal saline for treating septic shock in children

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Phase 3 Interventional Children's Hospital of Philadelphia · NCT04102371

This study is testing whether using balanced fluids instead of normal saline can help children with septic shock recover better and avoid kidney problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment8800 (estimated)
Ages2 Months to 17 Years
SexAll
SponsorChildren's Hospital of Philadelphia Academic / other
Locations24 sites (Davis, California and 23 other locations)
Trial IDNCT04102371 on ClinicalTrials.gov

What this trial studies

This multicenter pragmatic clinical trial aims to evaluate the effectiveness and safety of balanced fluid resuscitation compared to 0.9% normal saline in children diagnosed with septic shock. The study will involve approximately 5,000 pediatric patients who will receive either type of fluid during their treatment in emergency departments. The trial seeks to determine if balanced fluids can reduce the risk of kidney injury and improve overall outcomes in these critically ill patients. By embedding the trial within everyday clinical practice, it aims to provide real-world evidence on the best fluid resuscitation strategy for septic shock.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 2 months to 18 years who are suspected of having septic shock and require fluid resuscitation.

Not a fit: Patients who are not experiencing septic shock or those who have already received significant fluid resuscitation prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for septic shock in children, potentially reducing mortality and kidney injury.

How similar studies have performed: Previous studies have suggested that balanced fluids may offer superior efficacy and safety compared to normal saline, but this trial aims to provide definitive evidence through a large-scale randomized controlled approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Males or females age \>2 months to \<18 years
2. Clinician concern for septic shock, operationalized as:

   1. a "positive" ED sepsis alert confirmed by a physician OR
   2. physician decision to treat for septic shock OR
   3. a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation
3. Administration of at least one IV/Intraosseous (IO) fluid bolus for resuscitation and additional fluid deemed likely to be necessary to treat poor perfusion, or clinician judgment that \>1 fluid bolus is highly likely to be required. Poor perfusion is defined as physician's judgement of hypotension or abnormal (either "flash" or "prolonged") capillary refill.
4. Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization
5. Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met

Exclusion Criteria:

1. Treating physician judges that patient's condition deems it unsafe to administer either NS or BF (since patients will be equally likely to receive NS or BF at time of study enrollment), including:

   1. Clinical suspicion for impending brain herniation
   2. Known hyperkalemia, defined as non-hemolyzed whole blood or plasma/serum potassium \> 6 mEq/L, based on data available at or before patient meets criteria for study enrollment
   3. Known hypercalcemia, defined as plasma/serum total calcium \>12 mg/dL or whole blood ionized calcium \>1.35 mmol/L, based on data available at or before patient meets criteria for study enrollment
   4. Known acute fulminant hepatic failure, defined as plasma/serum alanine aminotransferase (ALT) \>10,000 U/L or total bilirubin \>12.0 mg/dL, based on data available at or before patient meets criteria for study enrollment
   5. Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant
   6. Known history of severe renal impairment, defined as peritoneal dialysis or hemodialysis
   7. Known metabolic/mitochondrial disorder, inborn error of metabolism, or primary mineralocorticoid deficiency as reported by participant, legally authorized representative (LAR) or accompanying caregiver, or as listed in the medical record
   8. Other concern for which the treating clinician deems it unsafe to administer either NS or LR
2. Known pregnancy determined by routine history disclosed by patient and/or accompanying acquaintance.
3. Known prisoner
4. Known allergy to a crystalloid fluid
5. Indication of declined consent to participate based on presence of an opt-out bracelet with appropriate messaging embossed into the bracelet, the presence of the patient's name on an opt-out list that will be kept up-to-date and checked prior to randomization, or verbal "opt-out" prior to enrollment.

Where this trial is running

Davis, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ShockSepticSepsisSeptic ShockFluid resuscitationSalineBalanced FluidMortality
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.