Optimal Fluid Resuscitation for Multi-System Traumatic Injury

This study is currently recruiting participants.

Verified by University of Miami, September 2008

Sponsored by:	University of Miami
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00527098

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 crystalloid.

Condition
Trauma

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Optimal Fluid Resuscitation for Multi-System Traumatic Injury

Further study details as provided by University of Miami:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2009

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

Contacts

Contact: Kenneth Proctor, PhD	305-585-1178	kproctor@med.miami.edu
Contact: Mark McKenney, MD	305-585-1178	mmckenne@med.miami.edu

Locations

United States, Florida
Ryder Trauma Center	Recruiting
Miami, Florida, United States, 33136
Contact: Ron Manning, RN, MSPH 305-355-4972 rmanning@med.miami.edu

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator:	Kenneth Proctor, PhD	University of Miami
Study Director:	Mark McKenney, MD	University of Miami

More Information

Responsible Party:	University of Miami ( Kenneth Proctor, PhD )
Study ID Numbers:	20070108
Study First Received:	September 6, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00527098
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Trauma Resuscitation

Study placed in the following topic categories:

Wounds and Injuries

ClinicalTrials.gov processed this record on January 14, 2009