Clinical trial NCT04201704: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Northwell Health
name: Johns Hopkins University
name: Cornell University
name: Childress Institute for Pediatric Trauma
First posted: 2019-12-17
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Overall complications
timeFrame: Up to time of discharge (up to approximately 1 month)
Secondary outcomes:
measure: Number of Hours of Hospital Length of Stay
timeFrame: Up to time of discharge (up to approximately 1 month)
measure: Number of Hours of ICU Length of Stay
timeFrame: Up to time of discharge (up to approximately 1 month)
measure: Number of hours on Supplemental Oxygen
timeFrame: Up to time of discharge (up to approximately 1 month)
measure: Number of Hours on Ventilator
timeFrame: Up to time of discharge (up to approximately 1 month)
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: John R. Oishei Children's Hospital of Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester, Golisano Children's Hospital
state: New York
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Columbia University
name: Vincent P Duron, MD
role: PRINCIPAL_INVESTIGATOR
References:
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