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Fluid Resuscitation

Balanced Fluids for Pediatric Sepsis (PRoMPT BOLUS Trial)

Phase 3

Recruiting

Led By Fran Balamuth, MD PhD MSCE

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females age >2 months to <18 years

Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization

Must not have

Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 and day 27, prior to anticipated discharge or death, whichever comes first.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a balanced fluid solution is better than normal saline for children in septic shock, including whether it can help prevent kidney damage.

Who is the study for?

This trial is for children aged over 2 months and under 18 years with a physician's diagnosis of septic shock needing antibiotics and fluid resuscitation. It excludes those with certain metabolic disorders, known pregnancy, prisoners, allergies to crystalloid fluids, severe liver or kidney issues, high potassium or calcium levels, or if the clinician deems it unsafe.

What is being tested?

The study compares balanced fluids like Lactated Ringer and Plasma-lyte against Normal Saline in treating pediatric septic shock. The goal is to see if balanced fluids can better prevent kidney injury progression compared to saline.

What are the potential side effects?

Potential side effects may include reactions related to fluid overload such as swelling or electrolyte imbalances like abnormal sodium or potassium levels which could affect heart rhythm and overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 months and 18 years old.

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I have received 40 mL/kg or less of IV fluids before being selected for the study.

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I have been diagnosed with septic shock and need IV antibiotics and fluids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver problems, like cirrhosis or liver failure.

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My calcium levels are higher than normal.

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I am not pregnant, as confirmed by medical history or test.

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I am on dialysis for severe kidney problems.

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My potassium levels are higher than 6 mEq/L.

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My liver is not in acute failure; my ALT and bilirubin levels are not extremely high.

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My doctor is concerned about pressure in my brain possibly leading to serious complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 and day 27, prior to anticipated discharge or death, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 and day 27, prior to anticipated discharge or death, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 and day 27, prior to anticipated discharge or death, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with Major Adverse Kidney Events within 30 days (MAKE30)

Secondary study objectives

Hospital-free days alive between randomization and day 27

Proportion of participants with all-cause hospital mortality

Proportion of participants with all-cause mortality at 90 days

+11 more

Other study objectives

Kidney biomarkers measured from blood and urine samples

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Balanced fluids (BF)Experimental Treatment2 Interventions

Balanced fluids (BF), including Lactated Ringer's and Plasma-Lyte (PL), will be administered to patients randomized to the experimental arm. BF will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Group II: 0.9% "Normal" Saline Fluid (NS)Active Control1 Intervention

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plasma-lyte

2022

Completed Phase 3

~50

Lactated Ringer

2019

Completed Phase 4

~1240