Optimal Fluid Resuscitation for Trauma Patients

Trauma Clinical Trial

Official title:

Optimal Fluid Resuscitation for Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527098
• Other study ID #: 20070108
• Status: Completed
• Phase: N/A
• First received: September 6, 2007
• Last updated: February 20, 2013
• Start date: October 2007
• Est. completion date: July 2010

Study information

• Verified date: February 2013
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes.

Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Less than 18 or greater than 65 years old

• Pregnant or lactating

• No fluid resuscitation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Ryder Trauma Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (4)

Crookes 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. — View Citation

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. — View Citation

Kelly 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. — View Citation

King 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		From hospital arrival up to an average of 3.5 weeks	No