Reduced Fluid Volume for Pediatric Trauma

Recruiting at 6 trial locations

Overseen By Vincent P Duron, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Congenital heart disease, Chronic cardiac condition, Chronic kidney disease, Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 month

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal amount of IV fluid for children who have experienced trauma and are in critical care. For years, high volumes of IV fluid were standard, but recent studies with adults have suggested that giving less fluid is actually better. The study will compare a standard fluid amount with a reduced amount (also known as Reduced Fluid or Limited Fluid Resuscitation) to determine what works best for children. Eligible participants are children aged 6 months to 15 years admitted to the pediatric intensive care unit after recent trauma. As an unphased trial, this research offers a unique opportunity to improve critical care practices for children.

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 prior data suggests that this fluid management protocol is safe for pediatric trauma patients?

Research has shown that using less fluid in certain medical situations might be safer for children. One study examined how different fluid amounts affect kids after surgery and found that both more and less fluid were generally safe.

Another study focused on adults with sepsis, a serious infection, and checked for safety issues like the need for breathing machines and heart rhythm problems. These issues were low when less fluid was used. Although this study involved adults, it suggests that using less fluid can be safe.

In emergencies involving trauma and bleeding, a study examined how less fluid affects blood gas levels and suggested that using less fluid can be safe, even in critical situations.

While these studies aren't directly related to the specific trial under consideration, they indicate that using less fluid can be safe. It's important to remember that different patients might react differently, and this research helps guide safe practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to fluid management in pediatric trauma patients. Unlike traditional liberal IV fluid strategies, which provide fluids based on a full calculated maintenance rate, the trial investigates restricted fluid administration, offering only 70% of the typical maintenance amount. This could potentially reduce complications like fluid overload while still ensuring adequate perfusion and recovery. This novel method could redefine how fluids are managed in young trauma patients, aiming to enhance recovery with fewer side effects.

What evidence suggests that this trial's treatments could be effective for pediatric trauma?

This trial will compare two approaches to IV fluid management in pediatric trauma patients: a Liberal IV Fluid approach and a Restricted IV Fluid approach. Research has shown that giving less IV fluid to trauma patients can lead to better outcomes. One review found that for every 1% increase in fluid overload, the risk of death in critically ill children rose by 6%. Another study on emergency trauma cases found that limiting fluid improved blood gas levels, which are crucial for assessing health. Additional research found no increase in death rates when using less fluid in critical care settings. These findings suggest that using less fluid might be safer and more effective for treating children with trauma. ^{1 2 5 6 7}

Who Is on the Research Team?

Vincent P Duron, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Reduced Fluid

Trial Overview 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.

How Is the Trial Designed?

Group I: Restricted IV Fluid Experimental Treatment 4 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 Fluid Active Control 4 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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Childress Institute for Pediatric Trauma

Collaborator

Trials

2

Recruited

270+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Both fluid management protocols (Group A and Group B) for pediatric burn patients were found to be safe and effective within the first 24 hours post-burn, with all patients surviving during this period.

While Group A required a greater total fluid volume infused compared to Group B, there were no significant differences in overall fluid intake or urine output, suggesting that Group A may be a more convenient option for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two different fluid resuscitation management protocols for pediatric burn patients: A retrospective study. Huang, M., Chen, JF., Chen, LY., et al.[2019]

This study is a multicenter pilot trial involving 154 critically ill children under 18 years old, comparing a restrictive fluid management strategy to a standard liberal strategy to assess safety and efficacy in fluid therapy.

The trial aims to evaluate the feasibility of recruitment and the incidence of new-onset acute kidney injury and central venous thrombosis as safety endpoints, while also measuring fluid balance and survival free of pediatric intensive care as efficacy endpoints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1). Raman, S., Rahiman, S., Kennedy, M., et al.[2023]

In a study of 36,908 pediatric patients with severe sepsis, those receiving balanced fluids for resuscitation showed a significantly lower mortality rate (12.5% vs 15.9%) compared to those receiving unbalanced fluids after 72 hours.

Patients treated with balanced fluids also experienced a reduced prevalence of acute kidney injury (16.0% vs 19.2%) and required fewer days of vasoactive infusions, indicating better overall outcomes in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. Emrath, ET., Fortenberry, JD., Travers, C., et al.[2017]

In a study of 100 mechanically ventilated children over one year, a restricted maintenance fluid strategy (40% of maintenance) showed a trend towards lower fluid overload and mortality compared to a usual/liberal strategy (70-80%).

The restricted group also had significantly more ventilation-free days (23 vs. 17 days) and PICU-free days (19 vs. 15 days), indicating better overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). Charaya, S., Angurana, SK., Nallasamy, K., et al.[2023]

In a study of 60 patients with severe post-trauma capillary leak syndrome, a restrictive positive fluid balance strategy significantly reduced fluid intake and improved key health indicators, such as intra-thoracic blood volume and extravascular lung water, compared to a non-restrictive approach.

The restrictive strategy also led to lower rates of respiratory and gastrointestinal dysfunction, reduced intracranial hypertension, and shorter durations of mechanical ventilation and ICU stays, indicating better overall patient outcomes without increasing mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The impact of early restrictive positive fluid balance strategy on the prognosis of patients with severe trauma]. Yang, WJ., Feng, QG., Wei, K., et al.[2013]

In a study involving 15 piglets, the balanced electrolyte solution with 1% glucose (BS-G1) demonstrated the widest margin of safety during accidental hyperinfusion, causing only moderate hyperglycemia without significant adverse effects.

In contrast, the 40% glucose solution (G40) was found to be highly dangerous, leading to severe hyperglycemia, electrolyte imbalances, and cardiac arrest after only 50-75 ml/kg infusion, highlighting the risks of using high-concentration glucose solutions in fluid management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of glucose-containing solutions during accidental hyperinfusion in piglets. Witt, L., Osthaus, WA., Lücke, T., et al.[2018]

Aggressive volume expansion during the early resuscitation phase for critically ill children, particularly those in septic shock, significantly improves outcomes by enhancing tissue oxygen delivery.

After initial resuscitation, managing fluid balance to avoid positive fluid retention is crucial, as it is linked to shorter hospital stays and fewer complications, highlighting the need for more research on fluid management specifically in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluid management in the critically ill child. Raman, S., Peters, MJ.[2021]

In a study of 60 patients with traumatic hemorrhagic shock, targeting a mean arterial pressure (MAP) of 65-70 mmHg during restrictive fluid resuscitation was found to be more effective in reducing systemic inflammatory responses and improving hemodynamics compared to lower (60-65 mmHg) or higher (70-75 mmHg) MAP targets.

The middle MAP group (65-70 mmHg) showed significantly better outcomes in inhibiting pro-inflammatory factors like TNF-α and IL-6 while promoting the anti-inflammatory factor IL-10, indicating that this MAP range may be optimal for managing traumatic hemorrhagic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of different target blood pressure resuscitation on peripheral blood inflammatory factors and hemodynamics in patients with traumatic hemorrhagic shock]. Shao, Z., Du, Z., Wang, R., et al.[2019]

A meta-analysis of 11 studies, including randomized controlled trials and observational studies, suggests that liberal fluid resuscitation strategies in trauma patients may lead to higher mortality rates compared to restricted fluid strategies, with a risk ratio of 1.25 in randomized trials and an odds ratio of 1.14 in observational studies.

Despite these findings, the studies analyzed have a high risk of selection bias and clinical variability, indicating that the results should be interpreted cautiously and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liberal versus restricted fluid resuscitation strategies in trauma patients: a systematic review and meta-analysis of randomized controlled trials and observational studies*. Wang, CH., Hsieh, WH., Chou, HC., et al.[2018]

Rapid fluid resuscitation is effective and safe for pediatric patients experiencing severe dehydration or shock, significantly reducing morbidity and mortality, as supported by recent studies involving early aggressive fluid administration of up to 60 ml/kg within 1-2 hours.

While there are concerns about potential complications like fluid overload and electrolyte disturbances, these risks can be minimized through careful clinical assessment and monitoring during the resuscitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric rapid fluid resuscitation. Simpson, JN., Teach, SJ.[2011]

Citations

1. pediatrictraumasociety.org pediatrictraumasociety.org/Restricted-Fluid-Management.cgi

Effect of Restricted Fluid Management Strategy on ... We are conducting the first multicenter randomized controlled trial comparing a liberal fluid management strategy to a restricted fluid management strategy in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10631167/

Pilot randomized controlled trial of restricted versus liberal ... We conducted a two-part pilot randomized controlled trial (RCT) comparing liberal to restricted crystalloid fluid management in 50 pediatric post-operative (1– ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10689381/

study protocol for a pilot randomised controlled trial (REDUCE ... A recent systematic review reported a 6% increase in the odds of mortality for every 1% increase in fluid overload in critically ill children. A ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212663

Early Restrictive or Liberal Fluid Management for Sepsis ... The restrictive fluid strategy that was used in this trial did not result in significantly lower (or higher) mortality before discharge home by day 90 than the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509625004145

Application of Restrictive Fluid Resuscitation in Emergency ... The study aimed to observe the application of restrictive fluid resuscitation in emergency traumatic hemorrhagic shock (THS) and impact on blood gas indicators.

6. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01408-w

Pilot randomized controlled trial of restricted versus liberal ... We conducted a two-part pilot randomized controlled trial (RCT) comparing liberal to restricted crystalloid fluid management in 50 pediatric post-operative (1– ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560540/

Pediatric Fluid Management - StatPearls - NCBI Bookshelf This review describes an evidence-based approach in the treatment of dehydration in children and highlights the role of the interprofessional team.