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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
271
Patients will have a target minimum MAP of 50 for the case
Ben Taub General Hospital
Houston, Texas, United States
RECRUITING30 day survival
Time frame: 30 days
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 days
Rate of infectious complications (VAP, UTI, wound infections).
Time frame: 30 days