Effect of Giving Reduced Fluid in Children After Trauma

Last updated: May 2, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Packed Erythrocytes Units, Blood Product Unit volume

Plasma volume

Platelets volume

Clinical Study ID

NCT04201704
AAAR2083
  • Ages 6-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Trauma patients older than 6 months and younger than 15 years admitted to thepediatric 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 12hours or less)

Exclusion

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 defectrequiring surgery or medication

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

  • Patients with chronic kidney disease as defined by an abnormality of kidneystructure 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

Study Design

Total Participants: 250
Treatment Group(s): 4
Primary Treatment: Packed Erythrocytes Units, Blood Product Unit volume
Phase:
Study Start date:
August 27, 2018
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Johns Hopkins University Charlotte R. Bloomberg Children's Center

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • John R. Oishei Children's Hospital of Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • University at Buffalo

    Buffalo, New York 14068
    United States

    Site Not Available

  • Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • Northwell Health Cohen Children's Medical Center

    Queens, New York 11040
    United States

    Site Not Available

  • University of Rochester, Golisano Children's Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

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