跳至主要内容
临床试验/NCT00459160
NCT00459160Unknown不适用

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

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
271
试验地点
2
主要终点
30 day survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

30 day survival

时间窗: 30 days

次要结局

  • Sequential Organ Failure Assessment (SOFA) score(30 days)
  • APACHE II(30 days)
  • ARDS(30 days)
  • ICU length of stay(30 days)
  • Ventilator-free days(30 days)
  • Myocardial ischemia(30 days)
  • Stroke(30 days)
  • Acidosis (pH and BE)(30 days)
  • Coagulopathy by conventional labs and thromboelastogram(30 days)
  • Estimated blood loss(30 days)
  • Transfusion requirements(30 days)
  • Glasgow Outcome Score(30 days)
  • Quantification of leukocyte apoptosis(2 days)
  • Rate of infectious complications (VAP, UTI, wound infections).(30 days)

研究者

申办方类型
Other

研究点 (2)

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