Reduced Fluid Volume for Pediatric Trauma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Vincent 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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 2 3 5 10}

Research Team

Vincent P Duron, MD

Principal Investigator

Columbia University

Eligibility 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.

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.

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

Treatment Details

Interventions

• Reduced Fluid (Other)

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.

Participant Groups

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+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Childress Institute for Pediatric Trauma

Collaborator

Trials

2

Recruited

270+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Matthew DeLisa

Cornell University

Chief Executive Officer since 2019

PhD in Chemical Engineering from Cornell University

Tami Magnus

Cornell University

Chief Medical Officer since 2015

MBA from Binghamton University

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

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 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 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]

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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Fluid management in the critically ill child. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[The impact of early restrictive positive fluid balance strategy on the prognosis of patients with severe trauma]. [2013]

3. China 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]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. [2017]

5. India pubmed.ncbi.nlm.nih.gov

Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). [2023]

6. England 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). [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety of glucose-containing solutions during accidental hyperinfusion in piglets. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric rapid fluid resuscitation. [2011]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of two different fluid resuscitation management protocols for pediatric burn patients: A retrospective study. [2019]

10. United States 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*. [2018]