Recruiting

Target Mean Arterial Pressure

Sponsor:

Baylor College of Medicine

Code:

NCT00459160

Conditions

Hemorrhagic Shock

Trauma

Wounds, Penetrating

Shock, Traumatic

Multiple Trauma

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

Intraoperative Hypotensive Resuscitation

Study Details

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.

Conditions

Hemorrhagic Shock

Trauma

Wounds, Penetrating

Shock, Traumatic

Multiple Trauma

Study ID

NCT00459160

Start date

Jul, 2007

Status verified date

Nov, 2010

Completion date

Jul, 2011

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

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

Enrollment

271 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low MAP Group

Hypotensive Group with a target minimum MAP of 50 mmHg

no intervention: High MAP group

Non experimental group: These patients will have a target minimum MAP of 65 mm Hg

Interventions

Intraoperative Hypotensive Resuscitation

Patients will have a target minimum MAP of 50 for the case

Primary outcome measure

  • 30 day survival [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Matthew M Carrick, MD

713-873-4381mcarrick@bcm.edu

Locations

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Margie Higgins

traumatrial@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Dec 1, 2010

Last verified

Nov, 2010

Keywords

  • Hypotensive Resuscitation
  • Hypotensive Anesthesia
  • Hemorrhagic Shock
  • Penetrating Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2010-12-01.