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临床试验/NCT02560285
NCT02560285Unknown不适用

An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Mortality analysis

研究概览

简要总结

Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

  • To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures
  • Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.

详细描述

The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures.

Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

  • To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II> 5 or STS-score> 5);
  • Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures.

It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II.

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

入选标准

  • Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes
  • Mortality risk with STS score>5 or EuroSCORE II>5

排除标准

  • Isolated surgery on ascending aorta, aortic arch or descending aorta
  • Heart transplantation
  • Impossibility to include patient´s data in research

结局指标

主要结局

Mortality analysis

时间窗: 30 days

Patient´s mortality data collection following 30 days after the main procedure

次要结局

  • Deep sternal wound infection(30 days)
  • Bleeding requiring reoperation(30 days)
  • Sepsis(30 days)
  • Stroke with neurological consequences (pareses or plegia)(30 days)
  • ST-elevation Myocardial infarction(30 days)
  • Non- ST- elevation Myocardial infarction(30 days)
  • Endocarditis(30 days)
  • Respiratory failure(30 days)
  • Renal replacement therapy(30 days)
  • Hepatic failure(30 days)
  • Unplanned cardiac reoperation(30 days)
  • Unplanned cardiac percutaneous intervention(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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