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临床试验/NCT06554925
NCT06554925招募中不适用

SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

Jennifer Breel1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Postoperative mortality

研究概览

简要总结

The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at sort-term (within 30 days) and long-term (90 days and 1 year).

详细描述

There are now an increasing number of studies on preoperative cardiovascular differences in females and males, but no study to date has focused on a female-specific approach to perioperative anaesthesia and critical care in cardiac surgery patients.

Given the higher mortality and morbidity in females after cardiac surgery, as well as the abovementioned sex differences, it is likely that females require different perioperative care than males, for better and faster recovery.

The investigators hypothesise that females require different perioperative care (pathways) compared to males when undergoing cardiac surgery. The investigators would therefore like to investigate which factors are different in female and male patients, by setting up a database of perioperative parameters. By identifying the factors that adversely affect morbidity and mortality in females and linking these parameters, the investigators would like to improve outcome in fmales after cardiac surgery.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients > 18 years
  • All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.

排除标准

  • 未提供

结局指标

主要结局

Postoperative mortality

时间窗: Measured at 5 years postoperatively

Incidence of perioperative mortality

次要结局

  • Postoperative complications (Morbidity)(Measured at 365 days)
  • Development of a predictive risk score using a composite outcome(Up to 30 days postoperatively)

研究者

发起方
Jennifer Breel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jennifer Breel

Research coordinator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

研究点 (1)

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