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Effect of Giving Reduced Fluid in Children After Trauma

Primary Purpose

Critical Illness, Pediatrics, General Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balanced crystalloid solution volume administration
Packed Erythrocytes Units, Blood Product Unit volume
Plasma volume
Platelets volume
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring 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

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University Charlotte R. Bloomberg Children's Center
  • Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's HospitalRecruiting
  • Northwell Health Cohen Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Liberal IV Fluid

Restricted IV Fluid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall complications
Total number of complications defined as pulmonary edema, hemorrhage, deep cavity infection, anastomotic dehiscence, thrombosis, death, superficial wound infection, ileus, and pneumonia.

Secondary Outcome Measures

Number of Hours of Hospital Length of Stay
length of time in hospital to inpatient discharge in hours
Number of Hours of ICU Length of Stay
length of time in pediatric intensive care unit in hours
Number of hours on Supplemental Oxygen
length of time patient requires non-invasive supplemental O2 in hours
Number of Hours on Ventilator
length of time patient requires invasive ventilation in hours

Full Information

First Posted
December 12, 2019
Last Updated
September 16, 2022
Sponsor
Columbia University
Collaborators
Northwell Health, Johns Hopkins University, Cornell University, Childress Institute for Pediatric Trauma
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1. Study Identification

Unique Protocol Identification Number
NCT04201704
Brief Title
Effect of Giving Reduced Fluid in Children After Trauma
Official Title
Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Northwell Health, Johns Hopkins University, Cornell University, Childress Institute for Pediatric Trauma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Pediatrics, General Surgery, Fluid Therapy, Wounds and Injuries
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal IV Fluid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Restricted IV Fluid
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Balanced crystalloid solution volume administration
Other Intervention Name(s)
lactated ringers
Intervention Description
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Intervention Type
Other
Intervention Name(s)
Packed Erythrocytes Units, Blood Product Unit volume
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plasma volume
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Platelets volume
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall complications
Description
Total number of complications defined as pulmonary edema, hemorrhage, deep cavity infection, anastomotic dehiscence, thrombosis, death, superficial wound infection, ileus, and pneumonia.
Time Frame
Up to time of discharge (up to approximately 1 month)
Secondary Outcome Measure Information:
Title
Number of Hours of Hospital Length of Stay
Description
length of time in hospital to inpatient discharge in hours
Time Frame
Up to time of discharge (up to approximately 1 month)
Title
Number of Hours of ICU Length of Stay
Description
length of time in pediatric intensive care unit in hours
Time Frame
Up to time of discharge (up to approximately 1 month)
Title
Number of hours on Supplemental Oxygen
Description
length of time patient requires non-invasive supplemental O2 in hours
Time Frame
Up to time of discharge (up to approximately 1 month)
Title
Number of Hours on Ventilator
Description
length of time patient requires invasive ventilation in hours
Time Frame
Up to time of discharge (up to approximately 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent P Duron, MD
Phone
212-342-8586
Email
vd2312@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent P Duron, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University Charlotte R. Bloomberg Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Wawryszyn, RN MSN CCRP
Phone
410-955-3429
Email
bwawrys1@jhmi.edu
Facility Name
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent P Duron, MD
Phone
212-342-8586
Email
vd2312@cumc.columbia.edu
Facility Name
Northwell Health Cohen Children's Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Prince, MD
Phone
718-470-3636
Email
JPrince@northwell.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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7935634
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Effect of Giving Reduced Fluid in Children After Trauma

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