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

Tracking Information

First Received Date ^ICMJE

September 6, 2007

Last Updated Date

February 20, 2013

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00527098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optimal Fluid Resuscitation for Trauma Patients

Official Title ^ICMJE

Optimal Fluid Resuscitation for Trauma Patients

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult Trauma Patients

Condition ^ICMJE

Trauma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

119

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00527098

Other Study ID Numbers ^ICMJE

20070108

Has Data Monitoring Committee

Responsible Party

Kenneth Proctor, University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Kenneth G Proctor, PhD	University of Miami
Study Director:	Carl I Schulman, MD, MSPH	University of Miami

Information Provided By

University of Miami

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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