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

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

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.

Study Overview

• Status: Unknown
• Conditions: Trauma; Hemorrhagic Shock; Multiple Trauma; Wounds, Penetrating; Shock, Traumatic
• Intervention / Treatment: Procedure: Intraoperative Hypotensive Resuscitation

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 Type: Interventional
• Enrollment (Anticipated): 271
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew M Carrick, MD; Phone Number: 713-873-4381; Email: mcarrick@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Ben Taub General Hospital
      • Contact: Margie Higgins; Email: traumatrial@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low MAP Group; Hypotensive Group with a target minimum MAP of 50 mmHg	Procedure: Intraoperative Hypotensive Resuscitation; Patients will have a target minimum MAP of 50 for the case
NO_INTERVENTION: High MAP group; Non experimental group: These patients will have a target minimum MAP of 65 mm Hg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30 day survival	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Stroke	30 days
ICU length of stay	30 days
Sequential Organ Failure Assessment (SOFA) score	30 days
APACHE II	30 days
ARDS	30 days
Ventilator-free days	30 days
Myocardial ischemia	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Matthew M Carrick, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ANTICIPATED): July 1, 2011
• Study Completion (ANTICIPATED): July 1, 2011

Study Registration Dates

• First Submitted: April 9, 2007
• First Submitted That Met QC Criteria: April 9, 2007
• First Posted (ESTIMATE): April 11, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Hypotensive Anesthesia; Hypotensive Resuscitation; Hemorrhagic Shock; Penetrating Trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Wounds and Injuries; Shock; Shock, Hemorrhagic; Multiple Trauma; Shock, Traumatic; Wounds, Penetrating; Antihypertensive Agents
• Other Study ID Numbers: (ER) H-19631