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

Primary Purpose

Hemorrhagic Shock, Trauma, Wounds, Penetrating

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative Hypotensive Resuscitation
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock focused on measuring Hypotensive Resuscitation, Hypotensive Anesthesia, Hemorrhagic Shock, Penetrating Trauma

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ben Taub General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low MAP Group

High MAP group

Arm Description

Hypotensive Group with a target minimum MAP of 50 mmHg

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

Outcomes

Primary Outcome Measures

30 day survival

Secondary Outcome Measures

Sequential Organ Failure Assessment (SOFA) score
APACHE II
ARDS
ICU length of stay
Ventilator-free days
Myocardial ischemia
Stroke
Acidosis (pH and BE)
Coagulopathy by conventional labs and thromboelastogram
Estimated blood loss
Transfusion requirements
Glasgow Outcome Score
Quantification of leukocyte apoptosis
Rate of infectious complications (VAP, UTI, wound infections).

Full Information

First Posted
April 9, 2007
Last Updated
November 30, 2010
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00459160
Brief Title
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients
Official Title
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients Undergoing Laparotomy or Thoracotomy for Trauma: A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock, Trauma, Wounds, Penetrating, Shock, Traumatic, Multiple Trauma
Keywords
Hypotensive Resuscitation, Hypotensive Anesthesia, Hemorrhagic Shock, Penetrating Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low MAP Group
Arm Type
Experimental
Arm Description
Hypotensive Group with a target minimum MAP of 50 mmHg
Arm Title
High MAP group
Arm Type
No Intervention
Arm Description
Non experimental group: These patients will have a target minimum MAP of 65 mm Hg
Intervention Type
Procedure
Intervention Name(s)
Intraoperative Hypotensive Resuscitation
Intervention Description
Patients will have a target minimum MAP of 50 for the case
Primary Outcome Measure Information:
Title
30 day survival
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) score
Time Frame
30 days
Title
APACHE II
Time Frame
30 days
Title
ARDS
Time Frame
30 days
Title
ICU length of stay
Time Frame
30 days
Title
Ventilator-free days
Time Frame
30 days
Title
Myocardial ischemia
Time Frame
30 days
Title
Stroke
Time Frame
30 days
Title
Acidosis (pH and BE)
Time Frame
30 days
Title
Coagulopathy by conventional labs and thromboelastogram
Time Frame
30 days
Title
Estimated blood loss
Time Frame
30 days
Title
Transfusion requirements
Time Frame
30 days
Title
Glasgow Outcome Score
Time Frame
30 days
Title
Quantification of leukocyte apoptosis
Time Frame
2 days
Title
Rate of infectious complications (VAP, UTI, wound infections).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew M Carrick, MD
Phone
713-873-4381
Email
mcarrick@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew M Carrick, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie Higgins
Email
traumatrial@bcm.edu

12. IPD Sharing Statement

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

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