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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00459160
First received: April 9, 2007
Last updated: November 30, 2010
Last verified: November 2010

April 9, 2007
November 30, 2010
July 2007
July 2011   (final data collection date for primary outcome measure)
30 day survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
30 day survival
Complete list of historical versions of study NCT00459160 on ClinicalTrials.gov Archive Site
  • Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • APACHE II [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • ARDS [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Ventilator-free days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Myocardial ischemia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Acidosis (pH and BE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Coagulopathy by conventional labs and thromboelastogram [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Estimated blood loss [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Transfusion requirements [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Glasgow Outcome Score [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Quantification of leukocyte apoptosis [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Rate of infectious complications (VAP, UTI, wound infections). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Sequential Organ Failure Assessment (SOFA) score
  • APACHE II
  • ARDS
  • ICU length of stay
  • Ventilator-free days
  • Myocardial ischemia
  • Stroke
  • Acidosis (pH and BE)
  • Coagulopathy by conventional labs and thromboelastogram
  • Estimated blood loss
  • Transfusion requirements
  • Glasgow Outcome Score
  • Quantification of leukocyte apoptosis
  • Rate of infectious complications (VAP, UTI, wound infections).
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hemorrhagic Shock
  • Trauma
  • Wounds, Penetrating
  • Shock, Traumatic
  • Multiple Trauma
Procedure: Intraoperative Hypotensive Resuscitation
Patients will have a target minimum MAP of 50 for the case
  • Experimental: Low MAP Group
    Hypotensive Group with a target minimum MAP of 50 mmHg
    Intervention: Procedure: Intraoperative Hypotensive Resuscitation
  • No Intervention: High MAP group
    Non experimental group: These patients will have a target minimum MAP of 65 mm Hg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
271
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
No
Contact: Matthew M Carrick, MD 713-873-4381 mcarrick@bcm.edu
United States
 
NCT00459160
(ER) H-19631
Yes
Matthew M. Carrick, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Matthew M Carrick, MD Baylor College of Medicine
Baylor College of Medicine
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP