跳至主要内容
临床试验/NCT02479321
NCT02479321已完成不适用

Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture

Juan-Víctor Lorente, MD, PhD2 个研究点 分布在 1 个国家目标入组 568 人开始时间: 2015年6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
568
试验地点
2
主要终点
Percentage of patients who developed intraoperative haemodynamic instability

研究概览

简要总结

Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per 100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications during and after surgery partly explain this high morbidity and mortality. Most patients are frail and with multicomorbidity. Goal-Directed Hemodynamic Therapy (GDT) based on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative complications and improve survival. The objective of our study is to assess the efficacy of a goal-directed hemodynamic therapy in reducing perioperative complications. Patients and Methods: non-randomized intervention study with a historical control and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring surgical intervention. In the control group standard care was performed based on non-invasive, intermittent arterial pressure measurement, obtained every 5 minutes, continuous heart rate, and oxygen saturation. In the intervention group GDT based on noninvasive monitoring will be performed. The main outcome will be the percentage of patients with perioperative complications. Secondary outcomes: LOS and survival at 12 months of surgery.

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

入选标准

  • Hip fracture that require surgical treatment
  • Agree to participate and sign informed consent

排除标准

  • Pathological or traffic related fractures
  • Anesthetic contraindication for surgery
  • Refractures
  • Contraindication for hemodynamic monitoring
  • Physiocal less than 30 after 7 minutes
  • Psychomotor agitation that prevents hemodynamic monitoring

结局指标

主要结局

Percentage of patients who developed intraoperative haemodynamic instability

时间窗: Intraoperative period

Intraoperative haemodynamic instability, defined as one measurement of SAP \< 90 mmHg in the CG and for at least one minute in the IG and/or the need for a bolus of vasoconstrictor.

次要结局

  • Intraoperative arrhythmias(Intraoperative period)
  • Survival(One-year survival)
  • Postoperative complications(Postoperative period)
  • Hospital stay(Patients will be followed for the duration of hospital stay, an expected median of 11 days)

研究者

发起方
Juan-Víctor Lorente, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Juan-Víctor Lorente, MD, PhD

Medical Doctor

Althaia Xarxa Assistencial Universitària de Manresa

研究点 (2)

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