跳至主要内容
临床试验/NCT01326260
NCT01326260终止不适用

Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.

研究概览

简要总结

This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.

详细描述

The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of severe traumatic injury requiring emergent surgery
  • Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL)
  • Acidosis was treated with either THAM or "usual care" (defined as crystalloid either or without sodium bicarbonate)

排除标准

  • 未提供

结局指标

主要结局

Total amount of fluids and blood products used during the operative and 72 hr post-operative period.

时间窗: Operative period and ICU (72 hr) post-op period

Total amount of fluids and blood products used during the operative and 72 hr post-operative period.

次要结局

  • Intra-operative, intensive care unit and hospital mortality(From the operative procedure onset to discharge out of the ICU or expiration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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