Pilot randomized controlled trial of restricted versus liberal crystalloid fluid management in pediatric post-operative and trauma patients.
Vincent P Duron, Rika Ichinose, Latoya A Stewart...
https://pubmed.ncbi.nlm.nih.gov/37941073/Actively Recruiting
Led by Columbia University · Updated on 2026-05-07
250
Participants Needed
4
Research Sites
4 weeks
Total Duration
Researchers are investigating how much intravenous IV fluid should be given to critically ill pediatric trauma patients. The study aims to compare two fluid management strategiesliberal versus restricted fluid administrationto determine which leads to better outcomes. This research addresses the lack of a standard approach to fluid resuscitation in children after trauma, building on adult studies suggesting that giving less fluid may improve results. This randomized controlled trial involves around 10 centers and compares two fluid strategies in children aged between 6 months and 15 years admitted to pediatric intensive care units after trauma. One group receives fluids based on a standard maintenance rate calculated by weight, with larger boluses given if certain clinical criteria are met. The other group receives reduced fluid volumes calculated at 70% of the standard maintenance rate, with correspondingly smaller boluses. Transfusions of blood products are given as needed based on specific clinical thresholds. Fluid rates may be adjusted over time according to urine output and other measures. Participants will be closely monitored during their hospital stay, with researchers tracking overall complications up to discharge, which is typically within about one month. Other outcomes include length of hospital and ICU stay, time on supplemental oxygen, and time on a ventilator. The study uses clinical data, vital signs, and lab results to guide fluid management and assess safety. Participation duration depends on hospital stay length, with detailed assessments throughout the intensive care period.
CONDITIONS
Effect of Giving Reduced Fluid in Children After Trauma
V
Vincent P Duron, MD
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Columbia University
Lead Sponsor
Northwell Health
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Lower Volume IV Fluid Strategy | Higher Volume IV Fluid Strategy |
|---|---|---|
| What it is | A protocol of administering a reduced total volume of balanced isotonic crystalloid IV fluids to children and adolescents admitted to the PICU after trauma, following a set restrictive volume algorithm. | A protocol of administering a higher total volume of balanced isotonic crystalloid IV fluids, consistent with a more generous (liberal) fluid resuscitation strategy commonly used in pediatric trauma practice. |
| Role in the trial | Investigational strategy; tested for its effect on post-trauma complications compared with liberal fluid use. | Active comparator; reflects usual fluid practices for similar pediatric trauma patients. |
| Primary use | To reduce potential complications related to fluid overload after pediatric trauma, while maintaining adequate resuscitation. | To provide supportive care for trauma resuscitation using higher-volume IV fluids, aiming for circulation and perfusion support. |
| How it is given or performed | Balanced crystalloid IV fluids are administered at restricted volumes per protocol, with transfusions as indicated for bleeding and clinician discretion. | Balanced crystalloid IV fluids are administered at higher volumes per standard clinical judgment, including transfusions as indicated for bleeding. |
| Evidence status | Efficacy of restricted IV fluid strategy in reducing complications is under investigation. Some retrospective and early randomized studies suggest fluid overload increases morbidity, but optimal limitation remains uncertain. | Liberal fluid use is widely practiced, but accumulating evidence associates higher fluid volumes with increased risk of adverse outcomes such as edema, organ dysfunction, and longer ICU stay in critically ill children. |
| Important limitations | Clinical effectiveness and specific complication risks remain unproven, pending results of large randomized studies. Over-limitation may risk inadequate organ perfusion in trauma patients. | While common, the liberal volume approach may increase the risk of fluid overload, pulmonary edema, and other complications. Practice patterns remain variable and absence of a consensus guideline leaves uncertainty for the optimal strategy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to approximately 1 month or until hospital discharge
Participants receive either a liberal or restricted intravenous fluid management strategy based on randomized assignment to support their recovery after trauma in the pediatric intensive care unit.
Continuous care during hospital stay with clinical monitoring
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/12885479/Columbia University
Lead Sponsor
Northwell Health
Collaborating Sponsor