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

Trauma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00459160
• Other study ID #: (ER) H-19631
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2007
• Last updated: November 30, 2010
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: November 2010
• Source: Baylor College of Medicine
• Contact: Matthew M Carrick, MD
• Phone: 713-873-4381
• Email: mcarrick[@]bcm.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 271
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Multiple Trauma
• Shock
• Shock, Hemorrhagic
• Shock, Traumatic
• Trauma
• Wounds and Injuries
• Wounds, Penetrating

Intervention

Procedure:
• Intraoperative Hypotensive Resuscitation
Patients will have a target minimum MAP of 50 for the case

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day survival		30 days	Yes
Secondary	Sequential Organ Failure Assessment (SOFA) score		30 days	Yes
Secondary	APACHE II		30 days	Yes
Secondary	ARDS		30 days	Yes
Secondary	ICU length of stay		30 days	Yes
Secondary	Ventilator-free days		30 days	Yes
Secondary	Myocardial ischemia		30 days	Yes
Secondary	Stroke		30 days	Yes
Secondary	Acidosis (pH and BE)		30 days	Yes
Secondary	Coagulopathy by conventional labs and thromboelastogram		30 days	Yes
Secondary	Estimated blood loss		30 days	Yes
Secondary	Transfusion requirements		30 days	Yes
Secondary	Glasgow Outcome Score		30 days	Yes
Secondary	Quantification of leukocyte apoptosis		2 days	No
Secondary	Rate of infectious complications (VAP, UTI, wound infections).		30 days	Yes