RECRUITING

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Conditions

Shock Septic Sepsis Septic Shock Fluid resuscitation Saline Balanced Fluid Mortality Crystalloid PlasmaLyte Lactated Ringer's Kidney injury

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Quick Facts

Study Start:2020-08-25

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04102371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Fran L Balamuth, MD PhD MSCE

CONTACT

215-590-7295

BalamuthF@chop.edu

Weiss Scott, MD MSCE

CONTACT

800-416-4441

scott.weiss@nemours.org

Principal Investigator

Fran Balamuth, MD PhD MSCE

PRINCIPAL_INVESTIGATOR

Attending Physician, Emergency Department

Study Locations (Sites)

UC Davis: University of California, Davis

Davis, California, 95616

United States

CHLA: Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

UCSF Benioff Children's Hospital

San Francisco, California, 94143

United States

Children's Colorado: University of Colorado

Denver, Colorado, 80204

United States

Children's Hospital of Atlanta

Emory, Georgia, 30322

United States

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

Chicago, Illinois, 60611

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

CS Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Washington University

Saint Louis, Missouri, 63130

United States

NYU Langone

New York, New York, 10016

United States

Columbia: New York-Presbyterian Hospital

New York, New York, 10065-4870

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

Hasbro Children's Hospital

Providence, Rhode Island, 02903

United States

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

Dallas, Texas, 75235

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Universtity of Texas MD Anderson

Houston, Texas, 77030

United States

Primary Children's: University of Utah

Salt Lake City, Utah, 84113

United States

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23284

United States

Children's National Medical Center

Columbia, Washington, 20010

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Milwaukee (MCW): Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Fran Balamuth, MD PhD MSCE, PRINCIPAL_INVESTIGATOR, Attending Physician, Emergency Department

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-25

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2020-08-25

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Sepsis
Septic Shock
Fluid resuscitation
Saline
Balanced Fluid
Mortality
Crystalloid
PlasmaLyte
Lactated Ringer's
Kidney injury

Additional Relevant MeSH Terms

Shock
Septic