Optimal Fluid Resuscitation for Trauma Patients

• ClinicalTrials.gov Identifier: NCT00527098
• Recruitment Status: Completed
• First Posted: September 10, 2007
• Results First Posted: May 4, 2011
• Last Update Posted: February 22, 2013
• Sponsor: University of Miami
• Information provided by (Responsible Party): Kenneth Proctor, University of Miami

Study Description

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.

Condition or disease
Trauma

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 119 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Optimal Fluid Resuscitation for Trauma Patients
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: From hospital arrival up to an average of 3.5 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult Trauma Patients

Criteria

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

Contacts and Locations

Locations

United States, Florida

Ryder Trauma Center

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Kenneth G Proctor, PhD; University of Miami
• Study Director: Carl I Schulman, MD, MSPH; University of Miami

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Kenneth Proctor, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT00527098
• Other Study ID Numbers: 20070108
• First Posted: September 10, 2007
• Results First Posted: May 4, 2011
• Last Update Posted: February 22, 2013
• Last Verified: February 2013

Keywords provided by Kenneth Proctor, University of Miami:

Trauma Resuscitation

Additional relevant MeSH terms:

Wounds and Injuries