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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2 and day 27, prior to anticipated discharge or death, whichever comes first.
Awards & highlights
PRoMPT BOLUS 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.Check my eligibility
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.See study design
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.
PRoMPT BOLUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 months and 18 years old.
Select...
I have received 40 mL/kg or less of IV fluids before being selected for the study.
Select...
I have been diagnosed with septic shock and need IV antibiotics and fluids.
PRoMPT BOLUS Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with Major Adverse Kidney Events within 30 days (MAKE30)
Secondary outcome measures
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 moreOther outcome measures
Kidney biomarkers measured from blood and urine samples
PRoMPT BOLUS 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
Lactated Ringer
2019
Completed Phase 4
~1240
Find a Location
Who is running the clinical trial?
Queensland Children's HospitalUNKNOWN
2 Previous Clinical Trials
750 Total Patients Enrolled
Royal Children's HospitalOTHER
33 Previous Clinical Trials
220,862 Total Patients Enrolled
The Children's Hospital of WinnipegOTHER
4 Previous Clinical Trials
7,831 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 months and 18 years old.You are allergic to a type of fluid used during the study.I have severe liver problems, like cirrhosis or liver failure.Your doctor has determined that it is not safe for you to receive either normal saline (NS) or lactated Ringer's (LR) solution.My calcium levels are higher than normal.I've received IV fluids for resuscitation and may need more due to poor blood flow.I have received 40 mL/kg or less of IV fluids before being selected for the study.I am not pregnant, as confirmed by medical history or test.I am on dialysis for severe kidney problems.My potassium levels are higher than 6 mEq/L.My liver is not in acute failure; my ALT and bilirubin levels are not extremely high.My doctor thinks it's unsafe for me to receive certain treatments.The doctor is worried that you might have a severe infection called septic shock.My doctor has decided to treat me for septic shock.I have been diagnosed with septic shock and need IV antibiotics and fluids.My doctor is concerned about pressure in my brain possibly leading to serious complications.
Research Study Groups:
This trial has the following groups:- Group 1: Balanced fluids (BF)
- Group 2: 0.9% "Normal" Saline Fluid (NS)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any medical risks associated with Plasma-lyte?
"There is some data to support the efficacy of Plasma-lyte, and it has gone through multiple rounds of testing to show that it is safe, so it received a score of 3."
Answered by AI
Is this research project only testing individuals who are over 55 years old?
"The age range for people that this study is recruiting is 6 months to 17 years old."
Answered by AI
What are some other ways in which Plasma-lyte has been studied?
"There are 112 ongoing studies and 30 in Phase 3 specifically looking into the effects of Plasma-lyte. Many of these trials are based in Calgary, but there are 379 locations total running these studies."
Answered by AI
What medical conditions does Plasma-lyte help alleviate?
"Plasma-lyte can be used to fight symptoms like diarrhea, and it has been used in surgeries and for terminal patients."
Answered by AI
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