RECRUITING

Effect of Giving Reduced Fluid in Children After Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial

Quick Facts

Study Start:2018-08-27
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04201704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)
  2. * Patients admitted to the PICU directly from the Emergency Department (ED)
  3. * Patients admitted to the PICU from the operating room (OR)
  4. * Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)
  1. * Patients transferred to PICU from outside PICU or inpatient floor
  2. * Patients transferred to PICU from outside facility ED if \>12 hours
  3. * Patients expected to be discharged from the PICU within 24 hours
  4. * Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication
  5. * Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)
  6. * 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
  7. * Post-operative transplant, cardiac, and neurosurgical patients
  8. * Patients with traumatic brain injury
  9. * Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases)
  10. * Hypotension requiring vasopressor therapy
  11. * If massive transfusion protocol initiated

Contacts and Locations

Study Contact

Vincent P Duron, MD
CONTACT
212-342-8586
vd2312@cumc.columbia.edu

Principal Investigator

Vincent P Duron, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Johns Hopkins University Charlotte R. Bloomberg Children's Center
Baltimore, Maryland, 21205
United States
Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
United States
Northwell Health Cohen Children's Medical Center
Queens, New York, 11040
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Vincent P Duron, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-27
Study Completion Date2026-09

Study Record Updates

Study Start Date2018-08-27
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Fluid Therapy
  • Intensive Care Units, Pediatric
  • Critical Care
  • Wounds and Injuries
  • Multiple Trauma
  • Treatment Outcome
  • Postoperative Complications
  • Resuscitation
  • Hemodynamics
  • Infusions, Intravenous
  • Isotonic Solutions
  • Crystalloid Solutions
  • Diuretics
  • Organism Hydration Status
  • Body Water

Additional Relevant MeSH Terms

  • Critical Illness
  • Pediatrics
  • General Surgery
  • Fluid Therapy
  • Wounds and Injuries