A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hemorrhagic Shock Trauma Wounds, Penetrating Shock, Traumatic Multiple Trauma |
Procedure: Intraoperative Hypotensive Resuscitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 30 day survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- 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 ]
| Estimated Enrollment: | 271 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Matthew M Carrick, MD | 713-873-4381 | mcarrick@bcm.edu |
| United States, Texas | |
| Ben Taub General Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Margie Higgins traumatrial@bcm.edu | |
| Principal Investigator: | Matthew M Carrick, MD | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Matthew M. Carrick, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00459160 History of Changes |
| Other Study ID Numbers: | (ER) H-19631 |
| Study First Received: | April 9, 2007 |
| Last Updated: | November 30, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baylor College of Medicine:
|
Hypotensive Resuscitation Hypotensive Anesthesia Hemorrhagic Shock Penetrating Trauma |
Additional relevant MeSH terms:
|
Multiple Trauma Shock Shock, Hemorrhagic Shock, Traumatic Wounds and Injuries Wounds, Penetrating |
Pathologic Processes Hemorrhage Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013