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临床试验/NCT06229938
NCT06229938已完成不适用

Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
1
主要终点
Incidence of hypovolemia (%)

研究概览

简要总结

Prospective observational study, in which the primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.

This study aims to include 150 elderly patients aging 70 years or older undergoing scheduled major surgery. The passive leg raising test on 4 consecutive time points in the perioperative period.

详细描述

Rationale:

There is currently limited evidence available on the occurrence of perioperative hypovolemia in the elderly population, and whether this hypovolemic state is related to postoperative complications in these patients. More information regarding this relationship may be valuable in strategies aiming for a reduction in postoperative complications in the elderly. In particular, postoperative complications lead to long term morbidity, decrease quality of live, increase health care costs and are the most important factor of patient survival. Therefore, the present study aims to investigate how many elderly patients suffer from hypovolemia in the perioperative period, and how this relates to postoperative complications.

Objective:

The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.

Study design:

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

入选标准

  • Informed consent
  • Age 70 years or older
  • Scheduled for elective surgery
  • Procedures with expected postoperative stay of at least two days

排除标准

  • Procedure in ambulatory practice
  • Acute surgery
  • Patients with current cardiac arrhythmias
  • Symptoms of cardiovascular shock or decompensation at presentation
  • Impossible to perform measurements due to patient characteristics
  • Inability to comprehend patient information and consequences of the study

结局指标

主要结局

Incidence of hypovolemia (%)

时间窗: Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)

preoperative incidence of hypovolemia (stroke volume increase of 10% or more upon a passive leg raising manoeuvre)

次要结局

  • Postoperative mortality(30 day)
  • Anesthetic technique(intra-operative (duration of surgical procedure))
  • Postoperative care(30 day)
  • Blood transfusion(intra-operative (duration of surgical procedure))
  • Vaso-active therapy(intra-operative (duration of surgical procedure))
  • Postoperative complications(30 day)
  • Fluid administration(intra-operative (duration of surgical procedure))
  • Duration of surgery(intra-operative (duration of surgical procedure))

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolien SE Bulte

Principal investigator

Amsterdam UMC, location VUmc

研究点 (1)

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