Effect of Giving Reduced Fluid in Children After Trauma

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201704
• Other study ID #: AAAR2083
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Vincent P Duron, MD
• Phone: 212-342-8586
• Email: vd2312[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Balanced crystalloid solution volume administration
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University Charlotte R. Bloomberg Children's Center	Baltimore	Maryland
United States	Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital	New York	New York
United States	Northwell Health Cohen Children's Medical Center	Queens	New York

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Childress Institute for Pediatric Trauma, Cornell University, Johns Hopkins University, Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kasotakis G, Sideris A, Yang Y, de Moya M, Alam H, King DR, Tompkins R, Velmahos G; Inflammation and Host Response to Injury Investigators. Aggressive early crystalloid resuscitation adversely affects outcomes in adult blunt trauma patients: an analysis of the Glue Grant database. J Trauma Acute Care Surg. 2013 May;74(5):1215-21; discussion 1221-2. doi: 10.1097/TA.0b013e3182826e13. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2006 Mar 18;367(9514):902. Lancet. 2006 Mar 18;367(9514):897; author reply 900-2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Hours of Hospital Length of Stay	length of time in hospital to inpatient discharge in hours	Up to time of discharge (up to approximately 1 month)
Secondary	Number of Hours of ICU Length of Stay	length of time in pediatric intensive care unit in hours	Up to time of discharge (up to approximately 1 month)
Secondary	Number of hours on Supplemental Oxygen	length of time patient requires non-invasive supplemental O2 in hours	Up to time of discharge (up to approximately 1 month)
Secondary	Number of Hours on Ventilator	length of time patient requires invasive ventilation in hours	Up to time of discharge (up to approximately 1 month)