NCT04201704 · Columbia University
Effect of Giving Reduced Fluid in Children After Trauma
What this study is about
This study is designed to help decide how much given through a vein (IV) (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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Buffalo, New York
- New York, New York
- Rochester, New York
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations