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临床试验/NCT04934410
NCT04934410Unknown不适用

Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation

Heidelberg University0 个研究点目标入组 50 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
Post-Induction hypotension

研究概览

简要总结

The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD).

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

入选标准

  • Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)

排除标准

  • Pregnancy
  • Presence of another cardiac assist device in the patient (for example ECLS)
  • No consent of the patient

研究组 & 干预措施

Patients undergoing Implantation of left ventricular assist device (Etomidate)

High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is etomidate.

干预措施: Etomidate (Drug)

Patients undergoing Implantation of left ventricular assist device (Midazolam)

High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is midazolam.

干预措施: Midazolam (Drug)

Patients undergoing Implantation of left ventricular assist device (Sevoflurane)

High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is sevoflurane.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Post-Induction hypotension

时间窗: First 30 minutes after induction of anesthesia

The incidence of hypotension in the first 30 minutes after the induction of anesthesia

次要结局

  • Length of stay on the intensive care unit (ICU)(After the procedure and transport to intensive care unit, total time in hours until submission from I. Expected time frame is 48 to 96 hours.CU)
  • Antihypotensive drugs during the procedure(Begin of the procedure until end of the procedure)
  • Kidney(First 28 days after procedure)
  • Antihypotensive drugs after induction(First 30 minutes after induction of anesthesia)
  • Mortality(First 28 days after procedure)
  • Delirium(First 24 hours after the end of the procedure)

研究者

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

Dr. Adrian Stephan

Principal Investigator

Heidelberg University

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