Effect of Giving Reduced Fluid 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

Overview

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.

Detailed description

Aggressive fluid resuscitation has been the cornerstone of early post-operative and trauma management for decades. However, recent prospective adult studies have challenged this practice, linking high volume crystalloid resuscitation to increased mortality, cardiopulmonary, gastrointestinal and hematologic complications. A retrospective study the investigators recently performed at their quaternary-care children's hospital echoed these results. High quality prospective data is necessary to determine best practice guidelines in our pediatric surgery and trauma patients.

Currently, no standard exists to guide management of crystalloid fluid administration in trauma patients. Both liberal and restricted strategies are in use, dependent on physician discretion. The investigators propose the first randomized controlled trial (RCT) comparing a liberal to a restricted fluid management strategy in critically ill pediatric trauma patients. The objective of this comparative effectiveness study is to conduct a multicenter (around 10 sites) randomized controlled trial (RCT) to determine whether liberal or restricted fluid administration leads to better outcomes in these patients.

Interventions

• Other Balanced crystalloid solution volume administration
  Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
• Other Packed Erythrocytes Units, Blood Product Unit volume
  For patients designated as Bleeding, where hemoglobin \<7 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
• Other Plasma volume
  For patients designated as Bleeding, where International Normalized Ratio (INR) \> 1.5 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
• Other Platelets volume
  For patients designated as Bleeding, where platelets \< 50,000 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.

Primary outcome measures

• Overall complications [Time frame: Up to time of discharge (up to approximately 1 month)]

Secondary outcome measures (4)

• Number of Hours of Hospital Length of Stay [Time frame: Up to time of discharge (up to approximately 1 month)]
• Number of Hours of ICU Length of Stay [Time frame: Up to time of discharge (up to approximately 1 month)]
• Number of hours on Supplemental Oxygen [Time frame: Up to time of discharge (up to approximately 1 month)]
• Number of Hours on Ventilator [Time frame: Up to time of discharge (up to approximately 1 month)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• John R. Oishei Children's Hospital of Buffalo — Buffalo
• Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's H — New York
• University of Rochester, Golisano Children's Hospital — Rochester
• Le Bonheur Children's Hospital — Memphis

Publications

• Bickell WH, Wall MJ Jr, Pepe PE, Martin RR, Ginger VF, Allen MK, Mattox KL. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994 Oct 27;331(17):1105-9. doi: 10.1056/NEJM199410273311701. PMID 7935634
• Arikan AA, Zappitelli M, Goldstein SL, Naipaul A, Jefferson LS, Loftis LL. Fluid overload is associated with impaired oxygenation and morbidity in critically ill children. Pediatr Crit Care Med. 2012 May;13(3):253-8. doi: 10.1097/PCC.0b013e31822882a3. PMID 21760565
• Bouchard JE, Mehta RL. Fluid balance issues in the critically ill patient. Contrib Nephrol. 2010;164:69-78. doi: 10.1159/000313722. Epub 2010 Apr 20. PMID 20427995
• Coons BE, Tam S, Rubsam J, Stylianos S, Duron V. High volume crystalloid resuscitation adversely affects pediatric trauma patients. J Pediatr Surg. 2018 Nov;53(11):2202-2208. doi: 10.1016/j.jpedsurg.2018.07.009. Epub 2018 Jul 24. PMID 30072215
• Cotton BA, Guy JS, Morris JA Jr, Abumrad NN. The cellular, metabolic, and systemic consequences of aggressive fluid resuscitation strategies. Shock. 2006 Aug;26(2):115-21. doi: 10.1097/01.shk.0000209564.84822.f2. PMID 16878017
• Feinman M, Cotton BA, Haut ER. Optimal fluid resuscitation in trauma: type, timing, and total. Curr Opin Crit Care. 2014 Aug;20(4):366-72. doi: 10.1097/MCC.0000000000000104. PMID 24979715
• Fletcher JJ, Bergman K, Blostein PA, Kramer AH. Fluid balance, complications, and brain tissue oxygen tension monitoring following severe traumatic brain injury. Neurocrit Care. 2010 Aug;13(1):47-56. doi: 10.1007/s12028-010-9345-2. PMID 20376708
• Foland JA, Fortenberry JD, Warshaw BL, Pettignano R, Merritt RK, Heard ML, Rogers K, Reid C, Tanner AJ, Easley KA. Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis. Crit Care Med. 2004 Aug;32(8):1771-6. doi: 10.1097/01.ccm.0000132897.52737.49. PMID 15286557

Identifiers

NCT: NCT04201704 · AAAR2083

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗