Effect of Giving Reduced Fluid in Children After Trauma
Launched by COLUMBIA UNIVERSITY · Dec 14, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how much intravenous (IV) fluid should be given to children who have experienced trauma, such as injuries from accidents. Traditionally, doctors have given a lot of IV fluids to trauma patients, but recent studies in adults suggest that giving less fluid might actually help them recover better. This study aims to find out if the same is true for children, with the goal of creating clear guidelines for treating young trauma patients.
To be eligible for this trial, children must be between 6 months and 15 years old and have been admitted to the pediatric intensive care unit (PICU) directly from the emergency department or after surgery. Unfortunately, some children will not be able to participate, including those with certain heart or kidney conditions, traumatic brain injuries, or those who are expected to leave the PICU quickly. If a child joins the study, they can expect to receive careful monitoring and specific treatment related to their fluid needs, helping us learn more about the best care for young patients after trauma.
Gender
ALL
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
About Columbia University
Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Memphis, Tennessee, United States
Baltimore, Maryland, United States
New York, New York, United States
Queens, New York, United States
Buffalo, New York, United States
Rochester, New York, United States
Buffalo, New York, United States
Patients applied
Trial Officials
Vincent P Duron, MD
Principal Investigator
Columbia University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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