Clinical trial NCT00459160: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhagic Shock
Trauma
Wounds, Penetrating
Shock, Traumatic
Multiple Trauma
Keywords: Hypotensive Resuscitation
Hypotensive Anesthesia
Hemorrhagic Shock
Penetrating Trauma
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2007-04-11
Enrollment: 271
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 30 day survival
timeFrame: 30 days
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: 30 days
measure: APACHE II
timeFrame: 30 days
measure: ARDS
timeFrame: 30 days
measure: ICU length of stay
timeFrame: 30 days
measure: Ventilator-free days
timeFrame: 30 days
measure: Myocardial ischemia
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Acidosis (pH and BE)
timeFrame: 30 days
measure: Coagulopathy by conventional labs and thromboelastogram
timeFrame: 30 days
measure: Estimated blood loss
timeFrame: 30 days
measure: Transfusion requirements
timeFrame: 30 days
measure: Glasgow Outcome Score
timeFrame: 30 days
measure: Quantification of leukocyte apoptosis
timeFrame: 2 days
measure: Rate of infectious complications (VAP, UTI, wound infections).
timeFrame: 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Matthew M Carrick, MD
role: PRINCIPAL_INVESTIGATOR
References: