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| Name | Class |
|---|---|
| Northwell Health | OTHER |
| Johns Hopkins University | OTHER |
| Cornell University | OTHER |
| Childress Institute for Pediatric Trauma |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal IV Fluid | Active Comparator |
|
|
| Restricted IV Fluid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced crystalloid solution volume administration | Other | Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Hours of ICU Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent P Duron, MD | Contact | 212-342-8586 | vd2312@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vincent P Duron, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John R. Oishei Children's Hospital of Buffalo | Not yet recruiting | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7935634 | Background | 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. | |
| 21760565 | 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. |
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| UNKNOWN |
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| 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. |
|
| 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. |
|
| 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. |
|
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 | 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 | length of time patient requires invasive ventilation in hours | Up to time of discharge (up to approximately 1 month) |
| Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital | Recruiting | New York | New York | 10032 | United States |
|
| University of Rochester, Golisano Children's Hospital | Recruiting | Rochester | New York | 14642 | United States |
|
| Le Bonheur Children's Hospital | Recruiting | Memphis | Tennessee | 38103 | United States |
|
| 20427995 | 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. |
| 30072215 | 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. |
| 16878017 | 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. |
| 24979715 | 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. |
| 20376708 | 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. |
| 15286557 | Background | 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. |
| 23609270 | Background | 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. |
| 17414612 | 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. |
| 21307740 | 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. |
| 16714767 | 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. |
| 7674386 | 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. |
| 12145036 | 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. |
| 16917442 | 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. |
| 12885479 | 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. |
| 37941073 | Derived | 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. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D014947 | Wounds and Injuries |
| D009104 | Multiple Trauma |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D010953 | Plasma Volume |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D001810 | Blood Volume |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
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