Reduced Fluid Volume for Pediatric Trauma
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byVincent P Duron, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Congenital heart disease, Chronic cardiac condition, Chronic kidney disease, Traumatic brain injury, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is designed to help decide how much intravenous (IV) fluid should be given to pediatric trauma patients. No standard currently exists for managing fluids in critically ill pediatric trauma patients, and many fluid strategies are now in practice. For decades, trauma patients got high volumes of IV fluid. Recent studies in adults show that patients actually do better by giving less fluid. The investigators do not know if this is true in children and this study is designed to answer that question and provide guidelines for IV fluid management in children after trauma.
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 is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Reduced Fluid, Limited Fluid Resuscitation, Restrictive Fluid Management for pediatric trauma?
Research suggests that limiting fluid intake in critically ill children can reduce hospital stay length and complications. Additionally, using a restrictive fluid strategy in trauma patients may improve outcomes by managing fluid balance effectively.
12345Is reduced fluid volume treatment generally safe for children?
There is evidence suggesting that limiting fluid intake in critically ill children can reduce hospital stay and complications, but the safety of this approach is still being studied, and more high-quality trials are needed to confirm its safety.
16789How does the Reduced Fluid treatment differ from other treatments for pediatric trauma?
Reduced Fluid treatment, also known as Limited Fluid Resuscitation, is unique because it involves giving less fluid to children with trauma compared to traditional methods. This approach aims to prevent fluid overload, which can lead to complications and longer hospital stays, by carefully managing the amount of fluid given during treatment.
123510Eligibility Criteria
This trial is for children aged 6 months to less than 15 years who have experienced trauma and are admitted to the PICU from the ER or OR, or transferred from another facility's ED within 12 hours. It excludes those with chronic kidney disease, certain heart conditions, hypotension requiring vasopressors, massive transfusion protocol initiated, traumatic brain injury, or diseases affecting blood pressure and heart rate.Inclusion Criteria
I was admitted to the intensive care unit directly from surgery.
Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)
I am a trauma patient aged 6 months to 15 years admitted to the PICU.
+1 more
Exclusion Criteria
I have a heart condition from birth that needed surgery or medication.
I have a long-term heart condition like high blood pressure or irregular heartbeat.
I have had kidney problems for more than 3 months.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either a liberal or restricted fluid management strategy
Up to 1 month
Daily monitoring in ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how much IV fluid should be given to pediatric trauma patients in critical care. It compares traditional high-volume fluid strategies against newer approaches that suggest better outcomes with reduced fluids. The goal is to establish guidelines for managing IV fluids in these young patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted IV FluidExperimental Treatment4 Interventions
* Maintenance fluid rate calculated by 70% of 4-2-1 formula if \<110 kg: 4 mL/kg for first 0-10 kg, + 2 mL/kg for 11-20 kg, + 1 mL/kg for every kg \>20 kg
* Patients \>110 kg: maintenance is 105 mL/hr
* If same bolus criteria met: 10 mL/kg for patients \<50kg, or 500 mL if ≥50 kg
* If meet transfusion criteria: transfuse 10 mL/kg with packed red blood cells, platelets, or fresh frozen plasma by weight up to 250 mL. Patients \>25 kg get 250 mL per transfusion
* Diuresis (after minimum 24 hrs): if UO \<1 mL/kg/hr (or \<50 mL/hr if \>50 kg) then continue IV fluids at maintenance rate and bolus as needed. If UO 1-2 mL/kg/hr (or 50-100 mL/hr if \>50 kg) then decrease IV rate to ½ maintenance rate. If UO \>2 mL/kg/hr (or \>100 mL/hr if \>50 kg), and Lactate, systolic blood pressure, heart rate, creatinine normal then reduce to "keep vein open" and consider Furosemide for goal UO \>2-4 mL/kg/hr (100-200 mL/hr if \>50 kg) until euvolemic
Group II: Liberal IV FluidActive Control4 Interventions
* Maintenance fluid rate calculated by 4-2-1 formula for patients \<110kg: 4 mL/kg for first 0-10kg + 2 mL/kg for 11-20kg + 1 mL/kg for each kg \>20kg
* Patients \>110kg maintenance 150 mL/hr
* Bolus Criteria: change in 1 of: \>20% decrease in systolic blood pressure 50th percentile for age and sex, \>20% increase in heart rate over 50th percentile for age, base excess \> -5mmol/L, blood lactate \>2mmol/L, AND urine output (UO) \<1 mL/kg/hr if \<50kg or \<50 mL/hr if \>50kg
* If criteria met: bolus 20 mL/kg if \<50kg or 1 L if ≥50 kg
* For transfusion: give 10 mL/kg packed red blood cells, platelets, or fresh frozen plasma up to 250 mL. If \>25kg give 250 mL.
* Diuresis- after minimum 24hrs: if UO \<2 mL/kg/hr (or \<100 mL/hr if \>50 kg) continue maintenance rate and bolus per initial phase. If UO \>2 mL/kg/hr (or \>100 mL/hr if \>50kg), and lactate, systolic blood pressure, heart rate, creatinine are normal then lower IV fluid rate to ½ maintenance rate and then to "keep vein open" once on regular feeds
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins University Charlotte R. Bloomberg Children's CenterBaltimore, MD
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's HospitalNew York, NY
Northwell Health Cohen Children's Medical CenterQueens, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
Childress Institute for Pediatric TraumaCollaborator
Northwell HealthCollaborator
Cornell UniversityCollaborator
Johns Hopkins UniversityCollaborator
References
Fluid management in the critically ill child. [2021]Fluid management has a major impact on the duration, severity and outcome of critical illness. The overall strategy for the acutely ill child should be biphasic. Aggressive volume expansion to support tissue oxygen delivery as part of early goal-directed resuscitation algorithms for shock--especially septic shock--has been associated with dramatic improvements in outcome. Recent data suggest that the cost-benefit of aggressive fluid resuscitation may be more complex than previously thought, and may depend on case-mix and the availability of intensive care. After the resuscitation phase, critically ill children tend to retain free water while having reduced insensible losses. Fluid regimens that limit or avoid positive fluid balance are associated with a reduced length of hospital stay and fewer complications. Identifying the point at which patients change from the 'early shock' pattern to the later 'chronic critical illness' pattern remains a major challenge. Very little data are available on the choice of fluids, and most of the information that is available arises from studies of critically ill adults. There is therefore an urgent need for high-quality trials of both resuscitation and maintenance fluid regimens in critically ill children.
[The impact of early restrictive positive fluid balance strategy on the prognosis of patients with severe trauma]. [2013]To observe the impact of early restrictive positive fluid balance strategy on the prognosis of patients with trauma.
[Effects of different target blood pressure resuscitation on peripheral blood inflammatory factors and hemodynamics in patients with traumatic hemorrhagic shock]. [2019]To investigate the target blood pressure level of restrictive fluid resuscitation in patients with traumatic hemorrhagic shock.
Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. [2017]To evaluate outcomes in patients receiving balanced fluids for resuscitation in pediatric severe sepsis.
Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). [2023]To assess the impact of restricted vs. usual/liberal maintenance fluid strategy on fluid overload (FO) among mechanically ventilated children.
REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1). [2023]Intravenous fluid therapy is the most common intervention in critically ill children. There is an increasing body of evidence questioning the safety of high-volume intravenous fluid administration in these patients. To date, the optimal fluid management strategy remains unclear. We aimed to test the feasibility of a pragmatic randomised controlled trial comparing a restrictive with a standard (liberal) fluid management strategy in critically ill children.
Safety of glucose-containing solutions during accidental hyperinfusion in piglets. [2018]Errors in fluid management can lead to significant morbidity in children. We conducted an experimental animal study to determine the margin of safety in accidental hyperinfusion of different glucose and electrolyte containing solutions.
Pediatric rapid fluid resuscitation. [2011]Intravenous and enteral fluid resuscitation are frequently used therapies in the management of pediatric patients in emergency departments and critical care settings. Any state of intravascular fluid deficit, ranging from mild dehydration due to gastroenteritis to fulminant septic shock, requires careful assessment and early restoration of hemodynamic stability. Rapid fluid resuscitation has gained increased recognition since the most recent pediatric shock management guidelines. We sought to review the evidence for rapid fluid resuscitation and to outline its clinical indications, implementation, and potential associated risks.
A comparison of two different fluid resuscitation management protocols for pediatric burn patients: A retrospective study. [2019]Pediatric burn patients are more susceptible to burn shock than adults, and an effective fluid management protocol is critical to successful resuscitation. Our research aim was to investigate the safety and efficacy of two protocols for pediatric burn patients for use within the first 24h.
Liberal versus restricted fluid resuscitation strategies in trauma patients: a systematic review and meta-analysis of randomized controlled trials and observational studies*. [2018]Hemorrhage is responsible for most deaths that occur during the first few hours after trauma. Animal models of trauma have shown that restricting fluid administration can reduce the risk of death; however, studies in patients are difficult to conduct due to logistical and ethical problems. To maximize the value of the existing evidence, we performed a meta-analysis to compare liberal versus restricted fluid resuscitation strategies in trauma patients.