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临床试验/NCT03023618
NCT03023618已完成不适用

Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 180 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
主要终点
complication rate

研究概览

简要总结

In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •ASA 1-2 patients

排除标准

  • •Severe Caridiac Disease
  • •Renal Failure

研究组 & 干预措施

control group

No Intervention

patients before 2014, in which fluids were administered without FloTrac monitoring

case group

Active Comparator

patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)

干预措施: FloTrac (Device)

结局指标

主要结局

complication rate

时间窗: up to 30 days postoperatively

次要结局

  • Duration of hospitalization(an average of 30 days)

研究者

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

Dr.Andrea Russo

Principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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