Effect of Giving Reduced Fluid in Children After Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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Aggressive fluid resuscitation has been the cornerstone of early post-operative and trauma management for decades. However, recent prospective adult studies have challenged this practice, linking high volume crystalloid resuscitation to increased mortality, cardiopulmonary, gastrointestinal and hematologic complications. A retrospective study the investigators recently performed at their quaternary-care children's hospital echoed these results. High quality prospective data is necessary to determine best practice guidelines in our pediatric surgery and trauma patients. Currently, no standard exists to guide management of crystalloid fluid administration in trauma patients. Both liberal and restricted strategies are in use, dependent on physician discretion. The investigators propose the first randomized controlled trial (RCT) comparing a liberal to a restricted fluid management strategy in critically ill pediatric trauma patients. The objective of this comparative effectiveness study is to conduct a multicenter (around 10 sites) randomized controlled trial (RCT) to determine whether liberal or restricted fluid administration leads to better outcomes in these patients.

Official Title
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Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial

Conditions
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Critical Illness, Pediatrics, General Surgery, Fluid Therapy, Wounds and Injuries

Intervention / Treatment
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* Other: Balanced crystalloid solution volume administration
* Other: Packed Erythrocytes Units, Blood Product Unit volume
* Other: Plasma volume
* Other: Platelets volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU) Patients admitted to the PICU directly from the Emergency Department (ED) Patients admitted to the PICU from the operating room (OR) Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less) Exclusion Criteria: Patients transferred to PICU from outside PICU or inpatient floor Patients transferred to PICU from outside facility ED if >12 hours Patients expected to be discharged from the PICU within 24 hours 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) Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health Post-operative transplant, cardiac, and neurosurgical patients Patients with traumatic brain injury Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases) Hypotension requiring vasopressor therapy If massive transfusion protocol initiated

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal IV Fluid<br>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 | Other: Balanced crystalloid solution volume administration<br>* Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.<br>* Other names: lactated ringers;Other: Packed Erythrocytes Units, Blood Product Unit volume<br>* For patients designated as Bleeding, where hemoglobin <7 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>Other: Plasma volume<br>* For patients designated as Bleeding, where International Normalized Ratio (INR) > 1.5 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>Other: Platelets volume<br>* For patients designated as Bleeding, where platelets < 50,000 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>|
| Experimental: Restricted IV Fluid<br>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 | Other: Balanced crystalloid solution volume administration<br>* Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.<br>* Other names: lactated ringers;Other: Packed Erythrocytes Units, Blood Product Unit volume<br>* For patients designated as Bleeding, where hemoglobin <7 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>Other: Plasma volume<br>* For patients designated as Bleeding, where International Normalized Ratio (INR) > 1.5 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>Other: Platelets volume<br>* For patients designated as Bleeding, where platelets < 50,000 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complications | Total number of complications defined as pulmonary edema, hemorrhage, deep cavity infection, anastomotic dehiscence, thrombosis, death, superficial wound infection, ileus, and pneumonia. | Up to time of discharge (up to approximately 1 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hours of Hospital Length of Stay | length of time in hospital to inpatient discharge in hours | Up to time of discharge (up to approximately 1 month) | 
| Number of Hours of ICU Length of Stay | length of time in pediatric intensive care unit in hours | Up to time of discharge (up to approximately 1 month) | 
| Number of hours on Supplemental Oxygen | length of time patient requires non-invasive supplemental O2 in hours | Up to time of discharge (up to approximately 1 month) | 
| Number of Hours on Ventilator | length of time patient requires invasive ventilation in hours | Up to time of discharge (up to approximately 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Therapy, Intensive Care Units, Pediatric, Critical Care, Wounds and Injuries, Multiple Trauma, Treatment Outcome, Postoperative Complications, Resuscitation, Hemodynamics, Infusions, Intravenous, Isotonic Solutions, Crystalloid Solutions, Diuretics, Organism Hydration Status, Body Water