Effect of Giving Reduced Fluid in Children After Trauma

NCT04201704 | Recruiting DMC

• 1 other identifier: AAAR2083
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall complications

  Total number of complications defined as pulmonary edema, hemorrhage, deep cavity infection, anastomotic dehiscence, thrombosis, death, superficial wound infection, ileus, and pneumonia.

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

Secondary Outcomes (4)

• Number of Hours of Hospital Length of Stay

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

• Number of Hours of ICU Length of Stay

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

• Number of hours on Supplemental Oxygen

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

• Number of Hours on Ventilator

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

Study Arms (2)

Liberal IV Fluid

ACTIVE COMPARATOR

* 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

Other: Balanced crystalloid solution volume administration; Other: Packed Erythrocytes Units, Blood Product Unit volume; Other: Plasma volume; Other: Platelets volume

Restricted IV Fluid

EXPERIMENTAL

* 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

Other: Balanced crystalloid solution volume administration; Other: Packed Erythrocytes Units, Blood Product Unit volume; Other: Plasma volume; Other: Platelets volume

Interventions

Balanced crystalloid solution volume administration OTHER

Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.

Also known as: lactated ringers

Liberal IV Fluid; Restricted IV Fluid

Packed Erythrocytes Units, Blood Product Unit volume OTHER

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.

Liberal IV Fluid; Restricted IV Fluid

Plasma volume OTHER

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.

Liberal IV Fluid; Restricted IV Fluid

Platelets volume OTHER

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.

Liberal IV Fluid; Restricted IV Fluid

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Northwell Health: collaborator
• Johns Hopkins University: collaborator
• Cornell University: collaborator
• Childress Institute for Pediatric Trauma: collaborator

Study Sites (4)

John R. Oishei Children's Hospital of Buffalo

Buffalo, New York, 14203, United States

NOT YET RECRUITING

Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

RECRUITING

University of Rochester, Golisano Children's Hospital

Rochester, New York, 14642, United States

RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (17)

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  PMID: 7935634 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

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  PMID: 23609270 BACKGROUND

• Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.

  PMID: 17414612 BACKGROUND

• Ley EJ, Clond MA, Srour MK, Barnajian M, Mirocha J, Margulies DR, Salim A. Emergency department crystalloid resuscitation of 1.5 L or more is associated with increased mortality in elderly and nonelderly trauma patients. J Trauma. 2011 Feb;70(2):398-400. doi: 10.1097/TA.0b013e318208f99b.

  PMID: 21307740 BACKGROUND

• National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

  PMID: 16714767 BACKGROUND

• Owens TM, Watson WC, Prough DS, Uchida T, Kramer GC. Limiting initial resuscitation of uncontrolled hemorrhage reduces internal bleeding and subsequent volume requirements. J Trauma. 1995 Aug;39(2):200-7; discussion 208-9. doi: 10.1097/00005373-199508000-00004.

  PMID: 7674386 BACKGROUND

• Takil A, Eti Z, Irmak P, Yilmaz Gogus F. Early postoperative respiratory acidosis after large intravascular volume infusion of lactated ringer's solution during major spine surgery. Anesth Analg. 2002 Aug;95(2):294-8, table of contents. doi: 10.1097/00000539-200208000-00006.

  PMID: 12145036 BACKGROUND

• Watters JM, Tieu BH, Todd SR, Jackson T, Muller PJ, Malinoski D, Schreiber MA. Fluid resuscitation increases inflammatory gene transcription after traumatic injury. J Trauma. 2006 Aug;61(2):300-8; discussion 308-9. doi: 10.1097/01.ta.0000224211.36154.44.

  PMID: 16917442 BACKGROUND

• Leteurtre S, Martinot A, Duhamel A, Proulx F, Grandbastien B, Cotting J, Gottesman R, Joffe A, Pfenninger J, Hubert P, Lacroix J, Leclerc F. Validation of the paediatric logistic organ dysfunction (PELOD) score: prospective, observational, multicentre study. Lancet. 2003 Jul 19;362(9379):192-7. doi: 10.1016/S0140-6736(03)13908-6.

  PMID: 12885479 BACKGROUND

• Duron VP, Ichinose R, Stewart LA, Porigow C, Fan W, Rubsam JM, Stylianos S, Dorrello NV. Pilot randomized controlled trial of restricted versus liberal crystalloid fluid management in pediatric post-operative and trauma patients. Pilot Feasibility Stud. 2023 Nov 8;9(1):185. doi: 10.1186/s40814-023-01408-w.

  PMID: 37941073 DERIVED

MeSH Terms

Conditions

Critical Illness; Wounds and Injuries; Multiple Trauma; Postoperative Complications

Interventions

Ringer's Lactate; Plasma Volume

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Blood Volume; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemodynamics; Cardiovascular Physiological Phenomena

Study Officials

• Vincent P Duron, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent P Duron, MD

CONTACT

212-342-8586; vd2312@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: August 27, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)