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

Results First Received: April 1, 2011

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Prospective
Condition:	Trauma

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Hextend Plus Standard of Care	Hextend along with the routine Standard of Care Resuscitation Fluid
Standard of Care	Routine Standard of Care Resuscitation Fluid

Participant Flow: Overall Study

	Hextend Plus Standard of Care	Standard of Care
STARTED	36	83
COMPLETED	36	83
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Hextend Plus Standard of Care	Hextend along with the routine Standard of Care Resuscitation Fluid
Standard of Care	Routine Standard of Care Resuscitation Fluid
Total	Total of all reporting groups

Baseline Measures

	Hextend Plus Standard of Care	Standard of Care	Total
Number of Participants [units: participants]	36	83	119
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	36	83	119
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	39 ± 17	39 ± 17	39 ± 17
Gender [units: participants]
Female	7	17	24
Male	29	66	95
Region of Enrollment [units: participants]
United States	36	83	119

Outcome Measures

1. Primary:

Mortality [ Time Frame: From hospital arrival up to an average of 3.5 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Kenneth Proctor, PhD
Organization: University of Miami
phone: 305-243-4694
e-mail: kproctor@med.miami.edu

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, 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

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