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Reduced Fluid Volume for Pediatric Trauma

N/A

Recruiting

Led By Vincent P Duron, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted to the PICU from the operating room (OR)

Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to time of discharge (up to approximately 1 month)

Awards & highlights

Study Summary

This trial is investigating what is the best amount of IV fluid to give pediatric trauma patients.

Who is the study for?

This trial is for children aged 6 months to less than 15 years who have experienced trauma and are admitted to the PICU from the ER or OR, or transferred from another facility's ED within 12 hours. It excludes those with chronic kidney disease, certain heart conditions, hypotension requiring vasopressors, massive transfusion protocol initiated, traumatic brain injury, or diseases affecting blood pressure and heart rate.Check my eligibility

What is being tested?

The study tests how much IV fluid should be given to pediatric trauma patients in critical care. It compares traditional high-volume fluid strategies against newer approaches that suggest better outcomes with reduced fluids. The goal is to establish guidelines for managing IV fluids in these young patients.See study design

What are the potential side effects?

Potential side effects may include complications related to fluid overload such as breathing difficulties or swelling (edema), reactions at the infusion site like pain or infection, and imbalances in electrolytes which can affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the intensive care unit directly from surgery.

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I am a trauma patient aged 6 months to 15 years admitted to the PICU.

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I was admitted to the intensive care unit directly from the emergency room.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to time of discharge (up to approximately 1 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to time of discharge (up to approximately 1 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to time of discharge (up to approximately 1 month) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall complications

Secondary outcome measures

Number of Hours of Hospital Length of Stay

Number of Hours of ICU Length of Stay

Number of Hours on Ventilator

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Restricted IV FluidExperimental Treatment4 Interventions

Maintenance fluid rate calculated by 70% of 4-2-1 formula if <110 kg: 4 mL/kg for first 0-10 kg, + 2 mL/kg for 11-20 kg, + 1 mL/kg for every kg >20 kg Patients >110 kg: maintenance is 105 mL/hr If same bolus criteria met: 10 mL/kg for patients <50kg, or 500 mL if ≥50 kg If meet transfusion criteria: transfuse 10 mL/kg with packed red blood cells, platelets, or fresh frozen plasma by weight up to 250 mL. Patients >25 kg get 250 mL per transfusion Diuresis (after minimum 24 hrs): if UO <1 mL/kg/hr (or <50 mL/hr if >50 kg) then continue IV fluids at maintenance rate and bolus as needed. If UO 1-2 mL/kg/hr (or 50-100 mL/hr if >50 kg) then decrease IV rate to ½ maintenance rate. If UO >2 mL/kg/hr (or >100 mL/hr if >50 kg), and Lactate, systolic blood pressure, heart rate, creatinine normal then reduce to "keep vein open" and consider Furosemide for goal UO >2-4 mL/kg/hr (100-200 mL/hr if >50 kg) until euvolemic

Group II: Liberal IV FluidActive Control4 Interventions

Maintenance fluid rate calculated by 4-2-1 formula for patients <110kg: 4 mL/kg for first 0-10kg + 2 mL/kg for 11-20kg + 1 mL/kg for each kg >20kg Patients >110kg maintenance 150 mL/hr Bolus Criteria: change in 1 of: >20% decrease in systolic blood pressure 50th percentile for age and sex, >20% increase in heart rate over 50th percentile for age, base excess > -5mmol/L, blood lactate >2mmol/L, AND urine output (UO) <1 mL/kg/hr if <50kg or <50 mL/hr if >50kg If criteria met: bolus 20 mL/kg if <50kg or 1 L if ≥50 kg For transfusion: give 10 mL/kg packed red blood cells, platelets, or fresh frozen plasma up to 250 mL. If >25kg give 250 mL. Diuresis- after minimum 24hrs: if UO <2 mL/kg/hr (or <100 mL/hr if >50 kg) continue maintenance rate and bolus per initial phase. If UO >2 mL/kg/hr (or >100 mL/hr if >50kg), and lactate, systolic blood pressure, heart rate, creatinine are normal then lower IV fluid rate to ½ maintenance rate and then to "keep vein open" once on regular feeds

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Childress Institute for Pediatric TraumaUNKNOWN

1 Previous Clinical Trials

24 Total Patients Enrolled

Columbia UniversityLead Sponsor

1,432 Previous Clinical Trials

2,460,723 Total Patients Enrolled

5 Trials studying Critical Illness

286 Patients Enrolled for Critical Illness

Northwell HealthOTHER

458 Previous Clinical Trials

470,683 Total Patients Enrolled

1 Trials studying Critical Illness

200,000 Patients Enrolled for Critical Illness

Media Library

Reduced Fluid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04201704 — N/A

Critical Illness Research Study Groups: Liberal IV Fluid, Restricted IV Fluid

Critical Illness Clinical Trial 2023: Reduced Fluid Highlights & Side Effects. Trial Name: NCT04201704 — N/A

Reduced Fluid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04201704 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still possible for this research endeavor?

"This clinical trial, which was initially posted on August 27th 2018 and most recently revised on September 16th 2022, is actively searching for participants. This information can be found online at clinicialtrials.gov."

Answered by AI

How many volunteers are currently contributing to this medical trial?

"Affirmative. Clinicaltrials.gov states that this clinical study, which commenced on August 27th 2018, is currently searching for participants. A total of 250 patients must be recruited from 3 distinct medical centres."

Answered by AI

Is there an opportunity to partake in this medical experiment?

"This clinical trial is accepting candidates between the ages of 6 months and 15 with a history in general surgery. A total of 250 participants are sought for this research project."

Answered by AI

Does this research accept volunteers of 85 years and younger?

"This research requires that any participants have to be between 6 months and 15 years old. Furthermore, 162 trials are available for those below 18 while 744 cater towards elderly individuals above the age of 65."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Immediate Versus Delayed Fluid Resuscitation for Hypotensive Patients with Penetrating Torso Injuries

Bickell, William H., Matthew J. Wall Jr., Paul E. Pepe, R. Russell Martin, Victoria F. Ginger, Mary K. Allen, and Kenneth L. Mattox. 1994. “Immediate Versus Delayed Fluid Resuscitation for Hypotensive Patients with Penetrating Torso Injuries”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199410273311701.

Pediatric Critical Care MedicineJournal

Fluid Overload Is Associated with Impaired Oxygenation and Morbidity in Critically Ill Children*

Arikan, Ayse A., Michael Zappitelli, Stuart L. Goldstein, Amrita Naipaul, Larry S. Jefferson, and Laura L. Loftis. 2012. “Fluid Overload Is Associated with Impaired Oxygenation and Morbidity in Critically Ill Children*”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0b013e31822882a3.

Contributions to NephrologyJournal

Fluid Balance Issues in the Critically Ill Patient

Bouchard, José;e, and Ravindra L. Mehta. 2010. “Fluid Balance Issues in the Critically Ill Patient”. Contributions to Nephrology. S. Karger AG. doi:10.1159/000313722.

Neurocritical CareJournal