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A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients

NCT ID: NCT00459160

Last Updated: 2010-12-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-07-31

Brief Summary

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The goal of this study will be to determine if a lower than normal blood pressure during surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased chance of death.

Detailed Description

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For the proposed study, all trauma patients undergoing laparotomy or thoracotomy for trauma that had a systolic blood pressure \< 90 mmHg prior to going to the operating room will be randomized to one of two groups. The randomization will take place at the operating room door. The first group will have a target minimum mean arterial pressure of 50 mm Hg (LMAP) and the second group will have a target minimum mean arterial pressure of 65 mmHg (HMAP). Before the operating room and in all other aspects of their care the patients will be treated as per standard of care. Patients will then be followed to determine if there is a difference in 30 day survival between the two groups. Secondary outcome measures will be Sequential Organ Failure Assessment (SOFA) score, APACHE II, ARDS, ICU length of stay, myocardial ischemia, stroke, acidosis, coagulopathy by conventional labs and thromboelastogram, estimated blood loss, transfusion requirements, Glasgow Outcome Score, the presence of leukocyte apoptosis, the serum level of the pro-inflammatory cytokines, IL-6 and G-CSF, and the rate of infectious complications (VAP, UTI, Wound infections). Blood samples (20 ml each) will be taken at three time points: prior to randomization, immediately after the end of resuscitation protocol, and 24 hrs after randomization. Blood will be examined for the presence of leukocyte apoptosis and levels of IL-6 and G-CSF.

Conditions

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Hemorrhagic Shock Trauma Wounds, Penetrating Shock, Traumatic Multiple Trauma

Keywords

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Hypotensive Resuscitation Hypotensive Anesthesia Hemorrhagic Shock Penetrating Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low MAP Group

Hypotensive Group with a target minimum MAP of 50 mmHg

Group Type EXPERIMENTAL

Intraoperative Hypotensive Resuscitation

Intervention Type PROCEDURE

Patients will have a target minimum MAP of 50 for the case

High MAP group

Non experimental group: These patients will have a target minimum MAP of 65 mm Hg

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intraoperative Hypotensive Resuscitation

Patients will have a target minimum MAP of 50 for the case

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All adult patients seen in the Ben Taub emergency center that have suffered a trauma, have a systolic blood pressure less than 90mm Hg, and are going to the operating room for a laparotomy or thoracotomy

Exclusion Criteria

* Known or suspected head injury
* Age \> 45 years old, \<= 12 years old
* Incarcerated individuals
* Pregnant women
* Patients with an advanced directive that refuse resuscitation
* Patients with "opt-out" bracelets that signify their refusal of participation in the project
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Baylor College of Medicine

Principal Investigators

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Matthew M Carrick, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Ben Taub General Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew M Carrick, MD

Role: CONTACT

Phone: 713-873-4381

Email: [email protected]

Facility Contacts

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Margie Higgins

Role: primary

Other Identifiers

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(ER) H-19631

Identifier Type: -

Identifier Source: org_study_id