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Optimal Fluid Resuscitation for Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527098
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : May 4, 2011
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami

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

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.

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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

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527098

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United States, Florida
Ryder Trauma Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Kenneth G Proctor, PhD University of Miami
Study Director: Carl I Schulman, MD, MSPH University of Miami
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Responsible Party: Kenneth Proctor, Professor, University of Miami Identifier: NCT00527098    
Other Study ID Numbers: 20070108
First Posted: September 10, 2007    Key Record Dates
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:
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Wounds and Injuries