Effect of Giving Reduced Fluid in Children After Trauma (NCT04201704) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Giving Reduced Fluid in Children After Trauma
United States250 participantsStarted 2018-08-27
Plain-language 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.
Who can participate
Age range
6 Months – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall complications
Timeframe: Up to time of discharge (up to approximately 1 month)