Optimal Fluid Resuscitation for Trauma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami
ClinicalTrials.gov Identifier:
NCT00527098
First received: September 6, 2007
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Trauma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optimal Fluid Resuscitation for Trauma Patients

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Mortality [ Time Frame: From hospital arrival up to an average of 3.5 weeks ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: October 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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