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临床试验/NCT04402749
NCT04402749已完成不适用

The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy

Mahidol University1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
416
试验地点
1
主要终点
The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy

研究概览

简要总结

Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome.

详细描述

Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava.

Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited.

The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Adult patients with renal cancer undergoing nephrectomy

排除标准

  • Patients with incomplete data

结局指标

主要结局

The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy

时间窗: intraoperative period

Pulmonary embolism * Clinical suspicious:Systolic blood pressure \< 90 mmHg without other reasonable causes, partial pressure of oxygen in artery \< 80 mmHg * Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan

次要结局

  • The incidence of postoperative PE of renal cancer patient undergoing nephrectomy(until 7 days after surgery)
  • Length of stay(7 days after surgery)
  • Mortality rate at 30 days postoperative(30 days after surgery)
  • Number of patients with postoperative organ dysfunction(7 days after surgery)
  • Rate of TEE utilization(7 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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