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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.
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:
Information provided by (Responsible Party):

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
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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

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 ClinicalTrials.gov identifier (NCT number): NCT00527098


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