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临床试验/NCT01188993
NCT01188993已完成4 期

Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock

University Hospital, Limoges4 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
153
试验地点
4
主要终点
therapeutic procedure following the hemodynamic assessment

研究概览

简要总结

The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).

详细描述

Each patient will be assessed by both the transpulmonary thermodilution technique and TEE (H0). The two assessments will be performed in random order (central randomization stratified by participating center), but within 30 minutes (no change of ongoing treatment during the assessment period). Two investigators not involved in patient care and blinded to the results of the alternative technique will performed independently the hemodynamic assessment using one of the two modalities for hemodynamic assessment tested in the study. They will interpret the results at bedside and propose a therapeutic change to the attending physician, according to the hemodynamic profile. The latter will finally: precisely identify the clinical problem to be solved (e.g., therapeutic target of the Surviving Sepsis Campaign not reached, tissue hypoperfusion), choose a therapy adapted while taking into account the clinical scenario and the results of both the transpulmonary thermodilution and TEE, evaluate the efficacy of this treatment (problem solved or not) and its tolerance (potential side-effect attributable to the treatment). In addition, the presence or resolution of signs of tissue hypoperfusion will systematically be assessed at H6, H12 and H24. Primary and secondary outcomes will be assessed by an independent committee of experts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment

排除标准

  • < 18 yr-old
  • pregnancy
  • contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.

研究组 & 干预措施

septic shock TPT then TEE

Active Comparator

Group 1: Each patient will be assessed by both the transpulmonary thermodilution technique and transesophageal echocardiography (TEE)..

干预措施: early septic shock (Combination Product)

septic shock TEE then TPT

Active Comparator

Goup 2: Each patient will be assessed by both transesophageal echocardiography (TEE) and the transpulmonary thermodilution technique.

干预措施: early septic shock (Combination Product)

结局指标

主要结局

therapeutic procedure following the hemodynamic assessment

时间窗: 2 years

Changes in therapy proposed after the hemodynamic assessment (hemodynamic profile) by each of the two tested methods: blood volume expansion (preload responsiveness), positive inotrope (cardiac dysfunction), vasopressor (vasoplegia), no change in ongoing therapy or dose tapering (inotropes or vasopressor).

次要结局

  • efficacy and safety of therapeutic intervention(2 years)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (4)

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