Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.
The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.
In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.
In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities.
详细描述
Preamble
The Perioperative Outcome (POP-OUT) project aims to improve care for our patients and intends to build a community of physicians from all over the world being dedicated to that aim.
The purpose and vision of the Perioperative Outcome study project
In perioperative care outcome data about postoperative mortality and morbidity is rare. This project aims to fill that gap with a prospective international database collecting perioperative data of surgical patients and relate them to postoperative mortality and morbidity.
The project is planned as initial observational study to build up the structures and define the case. Subsequently, based on that initial project the investigators further develop the study platform. This platform should adapt, grow, and broaden according to the results and possibilities seen in the study generations year by year. The intention is not to set-up a study group that finishes its work if the study is performed, but they hand on the study to the next generation of the community.
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
- 否
入选标准
- •Patients undergoing elective surgery with increased postoperative morbidity and/or increased postoperative mortality
排除标准
- •Patients undergoing surgery in the field of obstetrics
- •Age < 18 years
- •Lack of written informed consent
- •Lack of language understanding
- •Unwillingness to store disease data on site and share anonymised data as part of the clinical trial
结局指标
主要结局
Incidence of postoperative complications
时间窗: From the time of surgery up to hospital discharge or up to the 30th postoperative day
The postoperative complications are graded according to the CLAVIEN-DINDO classification
Incidence of postoperative mortalities
时间窗: From the time of surgery up to one year after surgery, during hospital stay, at three, six, or twelve months after surgery
The incidence of postoperative mortality during the follow-up period
次要结局
- Intraoperative hemodynamic characteristics(Time period during surgery)
- Implementation rate of preoperative factors impacting postoperative outcome(During the 48 hours prior to surgery)
- Characteristics of perioperative care, time in perioperative units and the hospital(During hospital stay or up to the 30th postoperative day)
- Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description(During hospital stay or up to the 30th postoperative day)
- Co-morbidities of patients(At the day of surgery)
- Clinical frailty scale(During the 48 hours prior to surgery)
- Postoperative haemodynamic characteristics(Time period from the end of surgery up to the third postoperative day)
- Transfusion of blood components and administration of coagulation factors(During hospital stay or up to the 30th postoperative day)
- Score of the physical/pathological activity status of the patients(During the 48 hours prior to surgery)
- Characteristics of provision of anesthesia and type of pain therapy(Time period from the start of anaesthesia up to the third postoperative day)