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

History of Changes

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:

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

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

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

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 History of Changes
Other Study ID Numbers:	20070108
Study First Received:	September 6, 2007
Results First Received:	April 1, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Trauma Resuscitation

Additional relevant MeSH terms:

Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013

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