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Which IV fluid is safer for kids with sepsis? major trial gives answers

NCT ID NCT04102371

Disease control Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study tested whether a 'balanced' fluid (Lactated Ringer) is better than normal saline for children with septic shock. Over 9,000 kids participated across multiple hospitals. The goal was to see which fluid reduces the risk of serious kidney problems or death within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactated Ringer (balanced fluid) and normal saline (unbalanced fluid)
What this could lead to
If balanced fluids prove better, this could guide hospitals to use them routinely for children with sepsis, reducing kidney damage and improving survival.
What could go wrong
This is a large, completed Phase 3 trial, but the difference between fluids may be small, and results might not apply to all settings or age groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

9,041 people

The number who actually took part.

Started

Aug 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Sepsis Shock toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SEPTIC Shock

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CHLA: Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • CS Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Colorado: University of Colorado

    Denver, Colorado, 80204, United States

  • Children's Hospital of Atlanta

    Emory, Georgia, 30322, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23284, United States

  • Children's National Medical Center

    Columbia, Washington, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia: New York-Presbyterian Hospital

    New York, New York, 10065-4870, United States

  • Dallas Children's: Children's Medical Center Dallas/UT southwestern

    Dallas, Texas, 75235, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Lurie Children's: Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Milwaukee (MCW): Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Primary Children's: University of Utah

    Salt Lake City, Utah, 84113, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • UC Davis: University of California, Davis

    Davis, California, 95616, United States

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94143, United States

  • Washington University

    St Louis, Missouri, 63130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.