Balanced crystalloid solution volume administration for Critical Illness
Johns Hopkins University Charlotte R. Bloomberg Children's Center, Baltimore, MD
Critical Illness+4 More ConditionsBalanced crystalloid solution volume administration - OtherStudy Summary
This trial is investigating what is the best amount of IV fluid to give pediatric trauma patients.
Eligible Conditions
- Critical Illness
- Pediatrics
- Fluid Therapy
- General Surgery
- Wounds and Injuries
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to time of discharge (up to approximately 1 month)
Month 1
Number of Hours of Hospital Length of Stay
Number of Hours of ICU Length of Stay
Number of Hours on Ventilator
Number of hours on Supplemental Oxygen
Overall complications
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Liberal IV Fluid
1 of 2
Restricted IV Fluid
1 of 2
Active Control
Experimental Treatment
250 Total Participants · 2 Treatment Groups
Primary Treatment: Balanced crystalloid solution volume administration · No Placebo Group · N/A
Restricted IV FluidExperimental Group · 4 Interventions: Packed Erythrocytes Units, Blood Product Unit volume, Balanced crystalloid solution volume administration, Plasma volume, Platelets volume · Intervention Types: Other, Other, Other, Other
Liberal IV FluidActiveComparator Group · 4 Interventions: Packed Erythrocytes Units, Blood Product Unit volume, Balanced crystalloid solution volume administration, Plasma volume, Platelets volume · Intervention Types: Other, Other, Other, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to time of discharge (up to approximately 1 month)
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,335 Previous Clinical Trials
1,626,033 Total Patients Enrolled
6 Trials studying Critical Illness
1,786 Patients Enrolled for Critical Illness
Childress Institute for Pediatric TraumaUNKNOWN
Northwell HealthOTHER
431 Previous Clinical Trials
466,676 Total Patients Enrolled
1 Trials studying Critical Illness
200,000 Patients Enrolled for Critical Illness
Cornell UniversityOTHER
154 Previous Clinical Trials
14,088,581 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,115 Previous Clinical Trials
32,578,520 Total Patients Enrolled
12 Trials studying Critical Illness
206,246 Patients Enrolled for Critical Illness
Vincent P Duron, MDPrincipal InvestigatorColumbia University
Eligibility Criteria
Age 6 - 15 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Bickell, William H., Matthew J. Wall Jr., Paul E. Pepe, R. Russell Martin, Victoria F. Ginger, Mary K. Allen, and Kenneth L. Mattox. 1994. “Immediate Versus Delayed Fluid Resuscitation for Hypotensive Patients with Penetrating Torso Injuries”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199410273311701.
- Arikan, Ayse A., Michael Zappitelli, Stuart L. Goldstein, Amrita Naipaul, Larry S. Jefferson, and Laura L. Loftis. 2012. “Fluid Overload Is Associated with Impaired Oxygenation and Morbidity in Critically Ill Children*”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0b013e31822882a3.
- Bouchard, José;e, and Ravindra L. Mehta. 2010. “Fluid Balance Issues in the Critically Ill Patient”. Contributions to Nephrology. S. Karger AG. doi:10.1159/000313722.
- Fletcher, Jeffrey J., Karen Bergman, Paul A. Blostein, and Andreas H. Kramer. 2010. “Fluid Balance, Complications, and Brain Tissue Oxygen Tension Monitoring Following Severe Traumatic Brain Injury”. Neurocritical Care. Springer Science and Business Media LLC. doi:10.1007/s12028-010-9345-2.
- Kasotakis, George, Antonis Sideris, Yuchiao Yang, Marc de Moya, Hasan Alam, David R. King, Ronald Tompkins, and George Velmahos. 2013. “Aggressive Early Crystalloid Resuscitation Adversely Affects Outcomes in Adult Blunt Trauma Patients”. Journal of Trauma and Acute Care Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0b013e3182826e13.
- Coons, Barbara E., Sophia Tam, Jeanne Rubsam, Steven Stylianos, and Vincent Duron. 2018. “High Volume Crystalloid Resuscitation Adversely Affects Pediatric Trauma Patients”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2018.07.009.
- Foland, Jason A., James D. Fortenberry, Barry L. Warshaw, Robert Pettignano, Robert K. Merritt, Micheal L. Heard, Kris Rogers, Chris Reid, April J. Tanner, and Kirk A. Easley. 2004. “Fluid Overload Before Continuous Hemofiltration and Survival in Critically Ill Children: A Retrospective Analysis*”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ccm.0000132897.52737.49.
- “Comparison of Two Fluid-management Strategies in Acute Lung Injury”. 2006. “Comparison of Two Fluid-management Strategies in Acute Lung Injury”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa062200.
- Watters, Jennifer M., Brandon H. Tieu, S Rob Todd, Terisa Jackson, Patrick J. Muller, Darren Malinoski, and Martin A. Schreiber. 2006. “Fluid Resuscitation Increases Inflammatory Gene Transcription After Traumatic Injury”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ta.0000224211.36154.44.
- Cotton, Bryan A., Jeffrey S. Guy, John A. Morris, and Naji N. Abumrad. 2006. “The Cellular, Metabolic, and Systemic Consequences of Aggressive Fluid Resuscitation Strategies”. Shock. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.shk.0000209564.84822.f2.
- Ley, Eric J., Morgan A. Clond, Marissa K. Srour, Moshe Barnajian, James Mirocha, Dan R. Margulies, and Ali Salim. 2011. “Emergency Department Crystalloid Resuscitation of 1.5 L or More Is Associated with Increased Mortality in Elderly and Nonelderly Trauma Patients”. Journal of Trauma: Injury, Infection & Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ta.0b013e318208f99b.
- Klein, Matthew B., Douglas Hayden, Constance Elson, Avery B. Nathens, Richard L. Gamelli, Nicole S. Gibran, David N. Herndon, et al.. 2007. “The Association Between Fluid Administration and Outcome Following Major Burn”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.sla.0000252572.50684.49.
- Owens, Thomas M., William C. Watson, Donald S. Prough, Tatsuo Uchida, and George C. Kramer. 1995. “Limiting Initial Resuscitation of Uncontrolled Hemorrhage Reduces Internal Bleeding and Subsequent Volume Requirements”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005373-199508000-00004.
- Feinman, Marcie, Bryan A. Cotton, and Elliott R. Haut. 2014. “Optimal Fluid Resuscitation in Trauma”. Current Opinion in Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mcc.0000000000000104.
- Takl, Arzu, Zeynep Eti, Pnar Irmak, and F. Ylmaz Göğüş. 2002. “Early Postoperative Respiratory Acidosis After Large Intravascular Volume Infusion of Lactated Ringer’s Solution During Major Spine Surgery”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000539-200208000-00006.
- Leteurtre, Stéphane, Alain Martinot, Alain Duhamel, François Proulx, Bruno Grandbastien, Jacques Cotting, Ronald Gottesman, et al.. 2003. “Validation of the Paediatric Logistic Organ Dysfunction (PELOD) Score: Prospective, Observational, Multicentre Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(03)13908-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2018. "Effect of Giving Reduced Fluid in Children After Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201704.
Frequently Asked Questions
Is enrollment still possible for this research endeavor?
"This clinical trial, which was initially posted on August 27th 2018 and most recently revised on September 16th 2022, is actively searching for participants. This information can be found online at clinicialtrials.gov." - Anonymous Online Contributor
Unverified Answer
How many volunteers are currently contributing to this medical trial?
"Affirmative. Clinicaltrials.gov states that this clinical study, which commenced on August 27th 2018, is currently searching for participants. A total of 250 patients must be recruited from 3 distinct medical centres." - Anonymous Online Contributor
Unverified Answer
Is there an opportunity to partake in this medical experiment?
"This clinical trial is accepting candidates between the ages of 6 months and 15 with a history in general surgery. A total of 250 participants are sought for this research project." - Anonymous Online Contributor
Unverified Answer
Does this research accept volunteers of 85 years and younger?
"This research requires that any participants have to be between 6 months and 15 years old. Furthermore, 162 trials are available for those below 18 while 744 cater towards elderly individuals above the age of 65." - Anonymous Online Contributor
Unverified Answer