Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

PHASE3RecruitingINTERVENTIONAL
Enrollment

8,800

Participants

Timeline

Start Date

August 25, 2020

Primary Completion Date

January 31, 2026

Study Completion Date

August 31, 2026

Conditions
ShockSeptic
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).

Trial Locations (24)

10016

WITHDRAWN

NYU Langone, New York

15224

RECRUITING

Children's Hospital of Pittsburgh, Pittsburgh

19104

RECRUITING

The Children's Hospital of Philadelphia, Philadelphia

20010

RECRUITING

Children's National Medical Center, Columbia

23284

RECRUITING

Children's Hospital of Richmond at VCU, Richmond

30322

RECRUITING

Children's Hospital of Atlanta, Emory

43205

RECRUITING

Nationwide Children's Hospital, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

RECRUITING

CS Mott Children's Hospital, Ann Arbor

53226

RECRUITING

Milwaukee (MCW): Medical College of Wisconsin, Milwaukee

60611

RECRUITING

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

63130

RECRUITING

Washington University, St Louis

75235

RECRUITING

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

77030

RECRUITING

Texas Children's Hospital, Houston

WITHDRAWN

Universtity of Texas MD Anderson, Houston

80204

RECRUITING

Children's Colorado: University of Colorado, Denver

84113

RECRUITING

Primary Children's: University of Utah, Salt Lake City

90027

RECRUITING

CHLA: Children's Hospital Los Angeles, Los Angeles

94143

RECRUITING

UCSF Benioff Children's Hospital, San Francisco

95616

RECRUITING

UC Davis: University of California, Davis, Davis

98105

RECRUITING

Seattle Children's Hospital, Seattle

02115

RECRUITING

Boston Children's Hospital, Boston

10065-4870

RECRUITING

Columbia: New York-Presbyterian Hospital, New York

02903

RECRUITING

Hasbro Children's Hospital, Providence

All Listed Sponsors
collaborator

Boston Children's Hospital

OTHER

collaborator

Children's Healthcare of Atlanta

OTHER

collaborator

Children's Hospital Colorado

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Morgan Stanley Children's Hospital

OTHER

collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

collaborator

Children's Medical Center Dallas

OTHER

collaborator

Children's National Research Institute

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Hasbro Children's Hospital

OTHER

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Primary Children's Hospital

OTHER

collaborator

Seattle Children's Hospital

OTHER

collaborator

St. Louis Children's Hospital

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

University of California, Davis

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of Michigan

OTHER

collaborator

Kidz First Hospital Middlemore

UNKNOWN

collaborator

Gold Coast Hospital and Health Service

OTHER_GOV

collaborator

Queensland Children's Hospital

OTHER_GOV

collaborator

Westmead Children's Hospital

UNKNOWN

collaborator

Sydney Children's Hospitals Network

OTHER

collaborator

Perth Children's Hospital

UNKNOWN

collaborator

Starship Children's Hospital

UNKNOWN

collaborator

Monash Children's Hospital

UNKNOWN

collaborator

Women's and Children's Hospital, Australia

OTHER_GOV

collaborator

Royal Children's Hospital

OTHER

collaborator

Royal Darwin Hospital

UNKNOWN

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Virginia Commonwealth University

OTHER

collaborator

Alberta Children's Hospital

OTHER

collaborator

British Columbia Children's Hospital

OTHER

collaborator

Centre Hospitalier Univeritaire Sainte Justine

UNKNOWN

collaborator

Centre Hospitalier Universitaire de Quebec

UNKNOWN

collaborator

Children's Hospital of Eastern Ontario

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

IWK Health Centre

OTHER

collaborator

Jim Pattison Children's Hospital

UNKNOWN

collaborator

Kingston Health Sciences Centre

OTHER

collaborator

London Health Sciences Centre

OTHER

collaborator

McMaster Children's Hospital

OTHER

collaborator

Stollery Children's Hospital

OTHER

collaborator

The Children's Hospital of Winnipeg

OTHER

collaborator

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

NIH

collaborator

Pennsylvania Department of Health

OTHER_GOV

collaborator

Townsville University Hospital

OTHER

lead

Children's Hospital of Philadelphia

OTHER