Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

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.

Conditions

• Shock
• Septic

Interventions

DRUG

Lactated Ringer

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).

DRUG

Normal Saline

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

DRUG

Plasma-lyte

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).

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• Children's Medical Center Dallas

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Hasbro Children's Hospital

  collaborator OTHER

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

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Primary Children's Hospital

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Kidz First Hospital Middlemore

  collaborator UNKNOWN

• Gold Coast Hospital and Health Service

  collaborator OTHER_GOV

• Queensland Children's Hospital

  collaborator OTHER_GOV

• Westmead Children's Hospital

  collaborator UNKNOWN

• Sydney Children's Hospitals Network

  collaborator OTHER

• Perth Children's Hospital

  collaborator UNKNOWN

• Starship Children's Hospital

  collaborator UNKNOWN

• Monash Children's Hospital

  collaborator UNKNOWN

• Women's and Children's Hospital, Australia

  collaborator OTHER_GOV

• Royal Children's Hospital

  collaborator OTHER

• Royal Darwin Hospital

  collaborator UNKNOWN

• Virginia Commonwealth University

  collaborator OTHER

• Alberta Children's Hospital

  collaborator OTHER

• British Columbia Children's Hospital

  collaborator OTHER

• Centre Hospitalier Univeritaire Sainte Justine

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Quebec

  collaborator UNKNOWN

• Children's Hospital of Eastern Ontario

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Jim Pattison Children's Hospital

  collaborator UNKNOWN

• Kingston Health Sciences Centre

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• McMaster Children's Hospital

  collaborator OTHER

• Stollery Children's Hospital

  collaborator OTHER

• The Children's Hospital of Winnipeg

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Pennsylvania Department of Health

  collaborator OTHER_GOV

• Townsville University Hospital

  collaborator OTHER

• Hospital nacional de niños Costa Rica

  collaborator UNKNOWN

• Morgan Stanley Children's Hospital

  collaborator OTHER

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

• Fran Balamuth, MD PhD MSCE · Attending Physician, Emergency Department

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-25

Primary Completion

2025-12-01

Completion

2026-01-31

FDA Drug

Yes

Countries

• United States

Study Locations