Hemorrhagic ShockNCT00459160
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients
A study testing Intraoperative Hypotensive Resuscitation in people with Hemorrhagic Shock and Trauma, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Hemorrhagic Shock, Trauma, Wounds, Penetrating
- What is being tested?
- Intraoperative Hypotensive Resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Margie Higgins, traumatrial@bcm.edu
About this study
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
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.
Read the 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.
- Being tested
- Intraoperative Hypotensive Resuscitation
- Keywords
- Hypotensive Resuscitation, Hypotensive Anesthesia, Hemorrhagic Shock, Penetrating Trauma
- Medical subject headings
- Shock, Hemorrhagic, Wounds and Injuries, Wounds, Penetrating, Shock, Traumatic, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Hypotensive ResuscitationProcedure or surgery
Patients will have a target minimum MAP of 50 for the case
| Study group | Role | What they receive |
|---|---|---|
| Low MAP Group | Experimental | Hypotensive Group with a target minimum MAP of 50 mmHg Receives: Procedure: Intraoperative Hypotensive Resuscitation |
| High MAP group | No intervention | Non experimental group: These patients will have a target minimum MAP of 65 mm Hg |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day survival
Measured: 30 days
Secondary outcomes (14)
Sequential Organ Failure Assessment (SOFA) score
Measured: 30 days
APACHE II
Measured: 30 days
ARDS
Measured: 30 days
ICU length of stay
Measured: 30 days
Ventilator-free days
Measured: 30 days
Myocardial ischemia
Measured: 30 days
Stroke
Measured: 30 days
Acidosis (pH and BE)
Measured: 30 days
Coagulopathy by conventional labs and thromboelastogram
Measured: 30 days
Estimated blood loss
Measured: 30 days
Transfusion requirements
Measured: 30 days
Glasgow Outcome Score
Measured: 30 days
Quantification of leukocyte apoptosis
Measured: 2 days
Rate of infectious complications (VAP, UTI, wound infections).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Matthew M Carrick, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459160
- Sponsor's protocol ID
- (ER) H-19631
- Status last verified
- Nov 2010
- First submitted
- 9 Apr 2007
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00459160
- Acronym / sponsor ID
- (ER) H-19631
- Keywords
- Hypotensive Resuscitation, Hypotensive Anesthesia, Hemorrhagic Shock, Penetrating Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 271 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low MAP Group | Experimental | Procedure: Intraoperative Hypotensive ResuscitationHypotensive Group with a target minimum MAP of 50 mmHg |
| High MAP group | No intervention | –Non experimental group: These patients will have a target minimum MAP of 65 mm Hg |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Known or suspected head injury
- Age > 45 years old, <= 12 years old
- Incarcerated individuals
- Pregnant women
- Patients with an advanced directive that refuse resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Hypotensive ResuscitationPatients will have a target minimum MAP of 50 for the case | Procedure or surgery | Low MAP Group |
Primary outcome
30 day survival
Time frame: 30 days
14 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score
Time frame: 30 days
APACHE II
Time frame: 30 days
ARDS
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Ventilator-free days
Time frame: 30 days
Myocardial ischemia
Time frame: 30 days
Stroke
Time frame: 30 days
Acidosis (pH and BE)
Time frame: 30 days
Coagulopathy by conventional labs and thromboelastogram
Time frame: 30 days
Estimated blood loss
Time frame: 30 days
Transfusion requirements
Time frame: 30 days
Glasgow Outcome Score
Time frame: 30 days
Quantification of leukocyte apoptosis
Time frame: 2 days
Rate of infectious complications (VAP, UTI, wound infections).
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew M Carrick, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Hypotensive Resuscitation in people with Hemorrhagic Shock and Trauma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew M Carrick, MD (713-873-4381, mcarrick@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.