NCT04201704 Effect of Giving Reduced Fluid in Children After Trauma
| NCT ID | NCT04201704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2018-08-27 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2018-08-27 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Vincent P Duron, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT04201704 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 15 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04201704 currently recruiting?
Yes, NCT04201704 is actively recruiting participants. Contact the research team at vd2312@cumc.columbia.edu for enrollment information.
Where is the NCT04201704 trial being conducted?
This trial is being conducted at Buffalo, United States, New York, United States, Rochester, United States, Memphis, United States.
Who is sponsoring the NCT04201704 clinical trial?
NCT04201704 is sponsored by Columbia University. The principal investigator is Vincent P Duron, MD at Columbia University. The trial plans to enroll 250 participants.