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

Not Applicable

• Conditions: Hemorrhagic Shock; Trauma; Wounds, Penetrating; Shock, Traumatic; Multiple Trauma
• Interventions: Procedure: Intraoperative Hypotensive Resuscitation

• Registration Number: NCT00459160
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Study Start: 2007-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-01
• Primary Completion: 2011-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low MAP Group	Intraoperative Hypotensive Resuscitation	Hypotensive Group with a target minimum MAP of 50 mmHg

Primary Outcome Measures

Name	Time	Method
30 day survival	30 days

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score	30 days
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
Acidosis (pH and BE)	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

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States