Optimal Fluid Resuscitation for Trauma Patients

NCT ID: NCT00527098

Last Updated: 2013-02-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Trauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Proctor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth G Proctor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Carl I Schulman, MD, MSPH

Role: STUDY_DIRECTOR

University of Miami

Locations

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Ryder Trauma Center

Miami, Florida, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.jamcollsurg.2006.11.014.

Reference Type BACKGROUND
PMID: 17254930 (View on PubMed)

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. doi: 10.1097/01.ta.0000135162.85859.4c.

Reference Type BACKGROUND
PMID: 15454801 (View on PubMed)

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. doi: 10.1016/j.surg.2004.05.011.

Reference Type BACKGROUND
PMID: 15300202 (View on PubMed)

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. doi: 10.1097/01.TA.0000029042.37577.A6.

Reference Type BACKGROUND
PMID: 12855887 (View on PubMed)

Other Identifiers

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20070108

Identifier Type: -

Identifier Source: org_study_id

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