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临床试验/NCT02353910
NCT02353910已完成不适用

VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock

University of Utah0 个研究点目标入组 113 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
主要终点
Incidence of VTE

研究概览

简要总结

Prospective studies on the incidence of VTE during severe sepsis and septic shock remain absent, hindering efficacy assessments regarding current VTE prevention strategies in septic patients. The investigators will prospectively study consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients will provide informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per standard of care and according to the patients' primary team, will be recorded for all patients. Patients will undergo bilateral lower (and upper, if a central venous catheter [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The investigators will perform multivariate regression analyses to identify predictors of VTE.

研究设计

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

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU patients with severe sepsis and septic shock

排除标准

  • Admission diagnosis of acute VTE,
  • age < 13 years,
  • pregnancy,
  • severe chronic respiratory disease,
  • severe chronic liver disease (Child-Pugh Score of 11-15),
  • moribund patients not expected to survive 24 hours, and
  • acute myocardial infarction within 30 days.

结局指标

主要结局

Incidence of VTE

时间窗: 28 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Rondina, MD

Associate Professor

University of Utah

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