CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,041 enrolled
Drug / intervention
Lactated Ringer +2 moredrug
Likely dose
Lactated Ringer 100 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04102371
NCT04102371Phase 3Completed
CompareCT.gov

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Children's Hospital of Philadelphia·interventional·Posted Sep 25, 2019·Updated Mar 5, 2026

In Brief

A Phase 3 clinical trial evaluating Lactated Ringer, Normal Saline, and 1 other intervention for Shock and Septic. Completed, enrolled 9,041 participants across 22 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShock, Septic
CountriesUnited States
CollaboratorsBoston Children's Hospital, Children's Healthcare of Atlanta, Children's Hospital Colorado, Children's Hospital Los Angeles, University of Pittsburgh, Children's Hospital and Health System Foundation, Wisconsin, Children's Medical Center Dallas, Children's National Research Institute, Children's Hospital Medical Center, Cincinnati, Hasbro Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Nationwide Children's Hospital, Primary Children's Hospital, Seattle Children's Hospital, St. Louis Children's Hospital, Baylor College of Medicine, University of California, Davis, University of California, San Francisco, University of Michigan, Kidz First Hospital Middlemore, Gold Coast Hospital and Health Service, Queensland Children's Hospital, Westmead Children's Hospital, Sydney Children's Hospitals Network, Perth Children's Hospital, Starship Children's Hospital, Monash Children's Hospital, Women's and Children's Hospital, Australia, Royal Children's Hospital, Royal Darwin Hospital, Virginia Commonwealth University, Alberta Children's Hospital, British Columbia Children's Hospital, Centre Hospitalier Univeritaire Sainte Justine, Centre Hospitalier Universitaire de Quebec, Children's Hospital of Eastern Ontario, The Hospital for Sick Children, IWK Health Centre, Jim Pattison Children's Hospital, Kingston Health Sciences Centre, London Health Sciences Centre, McMaster Children's Hospital, Stollery Children's Hospital, The Children's Hospital of Winnipeg, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pennsylvania Department of Health, Townsville University Hospital, Hospital nacional de niños Costa Rica, Morgan Stanley Children's Hospital

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 25, 2019
Enrollment StartAug 25, 2020
Primary CompletionDec 1, 2025
Study CompletionJan 31, 2026
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 6.8 years ago

Interventions

Lactated Ringerdrug

LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

Normal Salinedrug

Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Plasma-lytedrug

PL is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).