250 Participants Needed

Reduced Fluid Volume for Pediatric Trauma

Recruiting at 6 trial locations
VP
Overseen ByVincent P Duron, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.16789

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.167910

Who Is on the Research Team?

VP

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.
See 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.
See 8 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted IV FluidExperimental Treatment4 Interventions
Group II: Liberal IV FluidActive Control4 Interventions

Find a Clinic Near You

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

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.
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.
[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 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.
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]

Citations

Fluid management in the critically ill child. [2021]
[Effects of different target blood pressure resuscitation on peripheral blood inflammatory factors and hemodynamics in patients with traumatic hemorrhagic shock]. [2019]
Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). [2023]
[The impact of early restrictive positive fluid balance strategy on the prognosis of patients with severe trauma]. [2013]
Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. [2017]
REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1). [2023]
Safety of glucose-containing solutions during accidental hyperinfusion in piglets. [2018]
Pediatric rapid fluid resuscitation. [2011]
A comparison of two different fluid resuscitation management protocols for pediatric burn patients: A retrospective study. [2019]
10.United Statespubmed.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]
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