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临床试验/NCT01456702
NCT01456702Unknown不适用

Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
intra- and postoperative volume

研究概览

简要总结

It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed protocoll for volume management.

详细描述

It is difficult in the majority of cases to estimate the correct intra-operative mass of fluid therapy for each patient und needs a high degree of clinical experience. Among circumstances and problems of surgery (kind of surgery, length of time, bleeding, loss of liquid via wound) and kind of anesthesia, are also the concomitant diseases of patients relevant for the action of all anesthetists. These concomitant diseases correct to detect and to deduce corresponding consequences calls likewise for high clinical experience. Furthermore, the pre-operative fasting is an important fact.

Considering all these influencing factors the anesthetist tends rather to apply to much volume during surgery, followed by much more problems in PACU and / or intensive care unit.

However, how much volume is correct for which patient during which kind of surgery? How could the investigators estimate the really intra vessel volume deficit? Which available parameters are helpful, which monitoring is useful? These questions confront daily every anesthetist.

Monitoring of clinical "traditional" factors such as diuresis, blood pressure und heart rate are from experience to inexactly. Actually exist in the experts no uniform opinion about the kind and amount of fluid administration, which to apply, as well as the adequate monitoring. The central venous pressure, a commonly used parameter, is falling more and more behind.

Cardiac filling pressures correlate bad with filling volume and are unsuitable parameters for fluid therapy. It seems that dynamic parameters such as stroke volume (SV) and stroke volume variation (SVV) are better markers. SV and SVV could be measured by usual invasive blood pressure via LiDCO- or FloTrac-Monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • electiv orthopedic surgery with intermediate risk surgery
  • signed informed consent
  • >18 years

排除标准

  • No consent for the study
  • Age < 18 years
  • Emergency surgery
  • Pregnant women
  • Jehovah's Witnesses
  • Myocardial infarction in the last 4 weeks
  • High-risk cardiac factors

结局指标

主要结局

intra- and postoperative volume

时间窗: surgical time + treatment time until discharched to the ward or a maximum of 10 hours

次要结局

  • treatment time in PACU, ICU, anesthetic recovery room(admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours)
  • incidence of delirium and PONV(admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours)
  • need of blood tranfusions(intra- and postoperative treatment time with a maximum of 10 hours postoperative)
  • incidence of vasopressors(intra- and postoperative treatment time until a maximum of 10h postoperative)

研究者

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

Michael Sander

Vice Chair

Charite University, Berlin, Germany

研究点 (2)

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