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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Tri

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 Summary: 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.
Sponsor: Baylor College of Medicine

Current Primary Outcome: 30 day survival [ Time Frame: 30 days ]

Original Primary Outcome: 30 day survival

Current Secondary Outcome:

  • Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 30 days ]
  • APACHE II [ Time Frame: 30 days ]
  • ARDS [ Time Frame: 30 days ]
  • ICU length of stay [ Time Frame: 30 days ]
  • Ventilator-free days [ Time Frame: 30 days ]
  • Myocardial ischemia [ Time Frame: 30 days ]
  • Stroke [ Time Frame: 30 days ]
  • Acidosis (pH and BE) [ Time Frame: 30 days ]
  • Coagulopathy by conventional labs and thromboelastogram [ Time Frame: 30 days ]
  • Estimated blood loss [ Time Frame: 30 days ]
  • Transfusion requirements [ Time Frame: 30 days ]
  • Glasgow Outcome Score [ Time Frame: 30 days ]
  • Quantification of leukocyte apoptosis [ Time Frame: 2 days ]
  • Rate of infectious complications (VAP, UTI, wound infections). [ Time Frame: 30 days ]


Original Secondary Outcome:

  • 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).


Information By: Baylor College of Medicine

Dates:
Date Received: April 9, 2007
Date Started: July 2007
Date Completion: July 2011
Last Updated: November 30, 2010
Last Verified: November 2010