- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201704
Effect of Giving Reduced Fluid in Children After Trauma
Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent P Duron, MD
- Phone Number: 212-342-8586
- Email: vd2312@cumc.columbia.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Not yet recruiting
- Johns Hopkins University Charlotte R. Bloomberg Children's Center
-
Contact:
- Barbara Wawryszyn, RN MSN CCRP
- Phone Number: 410-955-3429
- Email: bwawrys1@jhmi.edu
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital
-
Contact:
- Vincent P Duron, MD
- Phone Number: 212-342-8586
- Email: vd2312@cumc.columbia.edu
-
Queens, New York, United States, 11040
- Recruiting
- Northwell Health Cohen Children's Medical Center
-
Contact:
- Jose Prince, MD
- Phone Number: 718-470-3636
- Email: JPrince@northwell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Liberal IV Fluid
|
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Other Names:
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.
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.
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.
|
Experimental: Restricted IV Fluid
|
Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
Other Names:
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall complications
Time Frame: Up to time of discharge (up to approximately 1 month)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Hours of Hospital Length of Stay
Time Frame: Up to time of discharge (up to approximately 1 month)
|
length of time in hospital to inpatient discharge in hours
|
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)
|
length of time in pediatric intensive care unit in hours
|
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)
|
length of time patient requires non-invasive supplemental O2 in hours
|
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)
|
length of time patient requires invasive ventilation in hours
|
Up to time of discharge (up to approximately 1 month)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vincent P Duron, MD, Columbia University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR2083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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