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Reduced Fluid Volume for Pediatric Trauma

N/A

Recruiting

Led By Vincent P Duron, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted to the PICU from the operating room (OR)

Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)

Must not have

Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication

Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to time of discharge (up to approximately 1 month)

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating what is the best amount of IV fluid to give pediatric trauma patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to fluid overload such as breathing difficulties or swelling (edema), reactions at the infusion site like pain or infection, and imbalances in electrolytes which can affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the intensive care unit directly from surgery.

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I am a trauma patient aged 6 months to 15 years admitted to the PICU.

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I was admitted to the intensive care unit directly from the emergency room.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition from birth that needed surgery or medication.

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I have a long-term heart condition like high blood pressure or irregular heartbeat.

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I have had kidney problems for more than 3 months.

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I have had a traumatic brain injury.

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I need medication to manage my low blood pressure.

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I have had a transplant, heart surgery, or neurosurgery.

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I have been put on a massive transfusion protocol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to time of discharge (up to approximately 1 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to time of discharge (up to approximately 1 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to time of discharge (up to approximately 1 month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall complications

Secondary study objectives

Number of Hours of Hospital Length of Stay

Number of Hours of ICU Length of Stay

Number of Hours on Ventilator

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 10Eligibility criteria met