Optimal Fluid Resuscitation for Trauma Patients
1 other identifier
observational
119
1 country
1
Brief Summary
The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
May 4, 2011
CompletedFebruary 22, 2013
February 1, 2013
2.8 years
September 6, 2007
April 1, 2011
February 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
From hospital arrival up to an average of 3.5 weeks
Eligibility Criteria
Adult Trauma Patients
You may qualify if:
- Greater than or equal to 18 years old and less than 65 years old
- Admission with multi-system traumatic injury
- Admission to the intensive care unit
You may not qualify if:
- Less than 18 or greater than 65 years old
- Pregnant or lactating
- No fluid resuscitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ryder Trauma Center
Miami, Florida, 33136, United States
Related Publications (4)
Earle SA, de Moya MA, Zuccarelli JE, Norenberg MD, Proctor KG. Cerebrovascular resuscitation after polytrauma and fluid restriction. J Am Coll Surg. 2007 Feb;204(2):261-75. doi: 10.1016/j.jamcollsurg.2006.11.014.
PMID: 17254930BACKGROUNDCrookes BA, Cohn SM, Bonet H, Burton EA, Nelson J, Majetschak M, Varon AJ, Linden JM, Proctor KG. Building a better fluid for emergency resuscitation of traumatic brain injury. J Trauma. 2004 Sep;57(3):547-54. doi: 10.1097/01.ta.0000135162.85859.4c.
PMID: 15454801BACKGROUNDKing DR, Cohn SM, Proctor KG. Changes in intracranial pressure, coagulation, and neurologic outcome after resuscitation from experimental traumatic brain injury with hetastarch. Surgery. 2004 Aug;136(2):355-63. doi: 10.1016/j.surg.2004.05.011.
PMID: 15300202BACKGROUNDKelly ME, Miller PR, Greenhaw JJ, Fabian TC, Proctor KG. Novel resuscitation strategy for pulmonary contusion after severe chest trauma. J Trauma. 2003 Jul;55(1):94-105. doi: 10.1097/01.TA.0000029042.37577.A6.
PMID: 12855887BACKGROUND
MeSH Terms
Conditions
Results Point of Contact
- Title
- Kenneth Proctor, PhD
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth G Proctor, PhD
University of Miami
- STUDY DIRECTOR
Carl I Schulman, MD, MSPH
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 22, 2013
Results First Posted
May 4, 2011
Record last verified: 2013-02