Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459160
Status:
UNKNOWN
Last Update Posted:
2010-12-01
First Post:
2007-04-09
Brief Title:
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None