Vasopressin Deficiency in Hemorrhagic Shock

NCT ID: NCT01107314

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-04-30

Brief Summary

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In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.

Detailed Description

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This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period.

Conditions

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Body Response to Trauma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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trauma patient

SBP less than 90mmHg

Phlebotomy

Intervention Type OTHER

Blood draws (total 48 cc blood)

Interventions

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Phlebotomy

Blood draws (total 48 cc blood)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient is a male or female patient presumed to be at least 18 years of age;
* Patient has a reported or actual systolic blood pressure \< 90 mmHg within 1 hour of arrival to the Emergency Room;
* Patient has clinical evidence of acute traumatic injury;

Exclusion Criteria

* Patient is asystolic or requires CPR prior to arrival;
* Patient was transferred from an outside facility
* Patient known to be pregnant
* Patient known to be prisoner
Minimum Eligible Age

18 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen M Cohn, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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A-13969.2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-0528-H

Identifier Type: -

Identifier Source: org_study_id

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