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NCT Number: NCT04201704

Effect of Giving Reduced Fluid in Children After Trauma

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.

Recruiting

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Key information

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John R. Oishei Children's Hospital of Buffalo, Buffalo, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balanced crystalloid solution volume administration

Other

Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.

Other names: lactated ringers

Packed Erythrocytes Units, Blood Product Unit volume

Other

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.

Plasma volume

Other

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.

Platelets volume

Other

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent P Duron, MD

CONTACT

[email protected]

212-342-8586

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Childress Institute for Pediatric Trauma
  • Cornell University
  • Johns Hopkins University
  • Northwell Health

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2019
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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