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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00459160
First received: April 9, 2007
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Hemorrhagic Shock
Trauma
Wounds, Penetrating
Shock, Traumatic
Multiple Trauma
Procedure: Intraoperative Hypotensive Resuscitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 30 day survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • APACHE II [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • ARDS [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Ventilator-free days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Myocardial ischemia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Acidosis (pH and BE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Coagulopathy by conventional labs and thromboelastogram [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Estimated blood loss [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Transfusion requirements [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Glasgow Outcome Score [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Quantification of leukocyte apoptosis [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Rate of infectious complications (VAP, UTI, wound infections). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 271
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low MAP Group
Hypotensive Group with a target minimum MAP of 50 mmHg
Procedure: Intraoperative Hypotensive Resuscitation
Patients will have a target minimum MAP of 50 for the case
No Intervention: High MAP group
Non experimental group: These patients will have a target minimum MAP of 65 mm Hg

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459160

Contacts
Contact: Matthew M Carrick, MD 713-873-4381 mcarrick@bcm.edu

Locations
United States, Texas
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Margie Higgins       traumatrial@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Matthew M Carrick, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Matthew M. Carrick, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00459160     History of Changes
Other Study ID Numbers: (ER) H-19631
Study First Received: April 9, 2007
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Hypotensive Resuscitation
Hypotensive Anesthesia
Hemorrhagic Shock
Penetrating Trauma

Additional relevant MeSH terms:
Antihypertensive Agents
Multiple Trauma
Shock
Shock, Hemorrhagic
Shock, Traumatic
Wounds and Injuries
Wounds, Penetrating
Hemorrhage
Pathologic Processes
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014