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Effect of Giving Reduced Fluid in Children After Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201704
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Northwell Health
Johns Hopkins University
Cornell University
Childress Institute for Pediatric Trauma
Information provided by (Responsible Party):
Vincent Duron, Columbia University

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.

Condition or disease Intervention/treatment Phase
Critical Illness Pediatrics General Surgery Fluid Therapy Wounds and Injuries Other: Balanced crystalloid solution volume administration Other: Packed Erythrocytes Units, Blood Product Unit volume Other: Plasma volume Other: Platelets volume Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liberal IV Fluid
  • 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
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Other Name: lactated ringers

Other: Packed Erythrocytes Units, Blood Product Unit volume
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.

Other: Plasma volume
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.

Other: Platelets volume
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.

Experimental: Restricted IV Fluid
  • 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
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Other Name: lactated ringers

Other: Packed Erythrocytes Units, Blood Product Unit volume
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.

Other: Plasma volume
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.

Other: Platelets volume
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 Measures :
  1. Overall complications [ Time Frame: Up to time of discharge (up to approximately 1 month) ]
    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 :
  1. Number of Hours of Hospital Length of Stay [ Time Frame: Up to time of discharge (up to approximately 1 month) ]
    length of time in hospital to inpatient discharge in hours

  2. Number of Hours of ICU Length of Stay [ Time Frame: Up to time of discharge (up to approximately 1 month) ]
    length of time in pediatric intensive care unit in hours

  3. Number of hours on Supplemental Oxygen [ Time Frame: Up to time of discharge (up to approximately 1 month) ]
    length of time patient requires non-invasive supplemental O2 in hours

  4. Number of Hours on Ventilator [ Time Frame: Up to time of discharge (up to approximately 1 month) ]
    length of time patient requires invasive ventilation in hours



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201704


Contacts
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Contact: Vincent P Duron, MD 212-342-8586 vd2312@cumc.columbia.edu

Locations
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United States, Maryland
Johns Hopkins University Charlotte R. Bloomberg Children's Center Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Barbara Wawryszyn, RN MSN CCRP    410-955-3429    bwawrys1@jhmi.edu   
United States, New York
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
Contact: Vincent P Duron, MD    212-342-8586    vd2312@cumc.columbia.edu   
Northwell Health Cohen Children's Medical Center Recruiting
Queens, New York, United States, 11040
Contact: Jose Prince, MD    718-470-3636    JPrince@northwell.edu   
Sponsors and Collaborators
Columbia University
Northwell Health
Johns Hopkins University
Cornell University
Childress Institute for Pediatric Trauma
Investigators
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Principal Investigator: Vincent P Duron, MD Columbia University
Publications:

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Responsible Party: Vincent Duron, Assistant Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT04201704    
Other Study ID Numbers: AAAR2083
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincent Duron, Columbia University:
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
Additional relevant MeSH terms:
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Critical Illness
Wounds and Injuries
Disease Attributes
Pathologic Processes