Hemorrhagic Shock, Multiple Trauma, Shock, Traumatic, Trauma, Wounds, Penetrating
Conditions
Keywords
Hypotensive Resuscitation, Hypotensive Anesthesia, Hemorrhagic Shock, Penetrating Trauma
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.
Interventions
PROCEDUREIntraoperative Hypotensive Resuscitation
Patients will have a target minimum MAP of 50 for the case
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 day survival | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| APACHE II | 30 days |
| ARDS | 30 days |
| ICU length of stay | 30 days |
| Ventilator-free days | 30 days |
| Myocardial ischemia | 30 days |
| Stroke | 30 days |
| Sequential Organ Failure Assessment (SOFA) score | 30 days |
| Coagulopathy by conventional labs and thromboelastogram | 30 days |
| Estimated blood loss | 30 days |
| Transfusion requirements | 30 days |
| Glasgow Outcome Score | 30 days |
| Quantification of leukocyte apoptosis | 2 days |
| Rate of infectious complications (VAP, UTI, wound infections). | 30 days |
| Acidosis (pH and BE) | 30 days |
Countries
United States
Contacts
Primary ContactMatthew M Carrick, MD
Outcome results
None listed