Balanced Fluids for Pediatric Sepsis
(PRoMPT BOLUS Trial)
Recruiting in Palo Alto (17 mi)
+21 other locations
Overseen byFran Balamuth, MD PhD MSCE
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Children's Hospital of Philadelphia
Disqualifiers: Brain herniation, Hyperkalemia, Hypercalcemia, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on fluid resuscitation for septic shock in children.
What data supports the effectiveness of the treatment Lactated Ringer's and similar solutions for pediatric sepsis?
Research suggests that using balanced fluids like Lactated Ringer's or Plasma-Lyte instead of normal saline may improve outcomes for sepsis patients, as they are associated with fewer complications like kidney injury and metabolic acidosis (a condition where the body produces too much acid). These balanced solutions may lead to better recovery in children with sepsis.
12345Is it safe to use balanced fluids like Lactated Ringer's or Plasma-Lyte in humans?
Research shows that balanced fluids like Lactated Ringer's and Plasma-Lyte are generally safe for use in humans, with stable vital signs and no significant adverse effects reported in studies involving healthy volunteers and children undergoing surgery.
26789How is the treatment with balanced fluids different for pediatric sepsis?
Balanced fluids like Lactated Ringer's and Plasma-Lyte are different from normal saline because they are designed to more closely match the body's natural fluid composition, which may lead to better outcomes in pediatric sepsis by reducing risks like kidney injury and metabolic imbalances.
12345Eligibility Criteria
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.Inclusion Criteria
I am between 2 months and 18 years old.
Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met
I've received IV fluids for resuscitation and may need more due to poor blood flow.
+5 more
Exclusion Criteria
You are allergic to a type of fluid used during the study.
Known prisoner
I have severe liver problems, like cirrhosis or liver failure.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either balanced fluids (BF) or 0.9% normal saline (NS) for fluid resuscitation immediately after randomization through the next calendar day
1 day
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary endpoint being major adverse kidney events within 30 days
30 days
Extended Follow-up
Participants are monitored for additional outcomes such as all-cause mortality at 90 days
90 days
Participant Groups
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.
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.
Lactated Ringer is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
🇺🇸 Approved in United States as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
🇨🇦 Approved in Canada as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
🇯🇵 Approved in Japan as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
🇨🇳 Approved in China as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
🇨🇭 Approved in Switzerland as Lactated Ringer's for:
- fluid resuscitation after blood loss due to trauma or surgery
- sepsis
- acute pancreatitis
- burn injuries
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
Hasbro Children's HospitalProvidence, RI
Seattle Children's HospitalSeattle, WA
UCSF Benioff Children's HospitalSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Children's Hospital of PhiladelphiaLead Sponsor
Kingston Health Sciences CentreCollaborator
Townsville University HospitalCollaborator
Queensland Children's HospitalCollaborator
Royal Children's HospitalCollaborator
The Children's Hospital of WinnipegCollaborator
Westmead Children's HospitalCollaborator
Children's Hospital and Health System Foundation, WisconsinCollaborator
Perth Children's HospitalCollaborator
Townsville University HospitalCollaborator
References
A retrospective analysis of normal saline and lactated ringers as resuscitation fluid in sepsis. [2023]The Surviving Sepsis Campaign suggested preferential resuscitation with balanced crystalloids, such as Lactated Ringer's (LR), although the level of recommendation was weak, and the quality of evidence was low. Past studies reported an association of unbalanced solutions, such as normal saline (NS), with increased AKI risks, metabolic acidosis, and prolonged ICU stay, although some of the findings are conflicting. We have compared the outcomes with the preferential use of normal saline vs. ringer's lactate in a cohort of sepsis patients.
Effect of Early Balanced Crystalloids Before ICU Admission on Sepsis Outcomes. [2022]Studies suggest that using balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) rather than saline (0.9% sodium chloride) may improve outcomes for patients with sepsis in the ED and ICU.
0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU-a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial. [2021]Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plasma-Lyte 148 and Compound Sodium Lactate, represent potential alternatives but the evidence on optimal fluid choices in critically ill children remains scarce. This study aims to demonstrate whether balanced solutions, when used as intravenous fluid therapy, are able to reduce the incidence of a rise in serum chloride level compared to 0.9% sodium chloride in critically ill children.
Crystalloid Fluid Choice and Clinical Outcomes in Pediatric Sepsis: A Matched Retrospective Cohort Study. [2018]To test the hypothesis that resuscitation with balanced fluids (lactated Ringer [LR]) is associated with improved outcomes compared with normal saline (NS) in pediatric sepsis.
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study. [2020]Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.
Normal Saline Solution or Lactated Ringer's Solution to Enhance Lactate Clearance in Septic Patients After Initial Resuscitation in the ED: A Retrospective Cohort Trial. [2022]To compare the effect of isotonic crystalloid solutions between lactated Ringer's solution (LRS) and normal saline solution (NSS) on lactate clearance in septic patients at the emergency department (ED).
Changes in serum electrolyte and atrial natriuretic peptide concentrations, acid-base and haemodynamic status after rapid infusion of isotonic saline and Ringer lactate solution in healthy volunteers. [2019]Opinions differ on the use of isotonic sodium chloride and Ringer lactate solution for extracellular volume depletion. We have compared changes in serum electrolyte concentrations and acid-base and haemodynamic status after rapid infusion of 2 litre of either isotonic sodium chloride or Ringer lactate solution in healthy volunteers. Changes within groups were small and statistically insignificant. Central venous pressure changes were associated with secretion of atrial natriuretic peptide, but this response was delayed.
Comparison of hypertonic vs isotonic fluids during resuscitation of severely burned patients. [2018]The hypertonic lactate saline (HLS) solutions with mild concentration of sodium have been used in some burn centers to maintain plasma volume without infusing larger fluids volumes. To evaluate the fluid requirements during resuscitation with lactated Ringer's solution and to realize resuscitation with HLS, we suggest the following clinical trial. Specific objectives include fluid loads, sodium loads, and fluid accumulation.
A Comparative Study of Peri-Operative Fluid Therapy With Ringer Lactate and PlasmaLyte in Children Undergoing Intra-Abdominal Surgery: A Randomized Control Trial. [2023]Background In this study, we compared Ringer's lactate solution (RL) with PlasmaLyte (PL), a relatively new IV fluid, for perioperative fluid therapy in the pediatric population. Methods This prospective and interventional randomized comparative study was carried out after obtaining clearance from the Institutional Ethics Committee. The study period was from November 2016 to December 2017. Results Hemodynamic parameters such as SpO2, ETCO2, heart rate, blood pressure, temperature, and urine output were stable in both groups throughout the perioperative period without any statistically or clinically significant variations. Children receiving PL (group PL) had better acid-base status, serum electrolytes, and blood lactate profiles compared with children receiving RL (group RL), who had hyponatremia and increased blood lactate levels, which continued to increase in the immediate postoperative period. No significant differences in pH, pCO2, HCO3, serum potassium, serum chloride, blood urea, serum creatinine, or blood sugar were observed. Conclusions PL is better than RL for perioperative fluid therapy in children undergoing abdominal surgeries.