Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Completed · Phase 3

Conditions studied: Shock, Septic

In brief

The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.

Key facts

Study ID

NCT04102371

Run by

Children's Hospital of Philadelphia

People needed

9041

Starts

2020-08-25

Expected to finish

2026-01-31

Last updated by the study team

2026-03-05

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age >2 months to <18 years
• Clinician concern for septic shock, operationalized as:
• a "positive" ED sepsis alert confirmed by a physician OR
• physician decision to treat for septic shock OR
• a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation
• 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.
• Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization
• Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met

You may not qualify if…

• 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:
• Clinical suspicion for impending brain herniation
• 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
• 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
• 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
• Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant
• Known history of severe renal impairment, defined as peritoneal dialysis or hemodialysis
• 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
• Other concern for which the treating clinician deems it unsafe to administer either NS or LR
• Known pregnancy determined by routine history disclosed by patient and/or accompanying acquaintance.
• Known prisoner
• Known allergy to a crystalloid fluid
• 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 it is running

• UC Davis: University of California, Davis — Davis, California, United States
• CHLA: Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Children's Colorado: University of Colorado — Denver, Colorado, United States
• Children's Hospital of Atlanta — Emory, Georgia, United States
• Lurie Children's: Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Columbia: New York-Presbyterian Hospital — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Hasbro Children's Hospital — Providence, Rhode Island, United States
• Dallas Children's: Children's Medical Center Dallas/UT southwestern — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's: University of Utah — Salt Lake City, Utah, United States
• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States
• Children's National Medical Center — Columbia, Washington, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Milwaukee (MCW): Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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