Evaluation of hsTnT for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,598
- 试验地点
- 1
- 主要终点
- postoperative complications determined with the calvien-dindo classification
研究概览
简要总结
Aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. Several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.
详细描述
The aim of this secondary analysis of the SUPERADD study is to use the perioperative data from the prospective SUPERADD study ("SUbstitution of PERioperative Albumin Deficiency Disorders") (Eudra-CT 2016-001313-24; Clinical Trials NCT03167645; DOI: 10.1097) to identify risk factors for the occurrence of postoperative complications, based on the Clavien-Dindo classification in the nine domains of the Postoperative Morbidity Survey.
Multivariate Analyses, Decision trees, time series analysis and Machine Learning methods will be applied to distinguish risk factors for postoperative complikations and mortality in a high-risk group (see publication of the statistical analysis plan and its enhancement).
Patients participating in the SUPERADD study (NCT03167656) and who had at least two perioperative high sensitive Troponin T (hsTnT) values in order to detect myocardial injury were included in this secondary analysis as hsTnT is associated with major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery and mortality.
The secondary analysis uses data obtained at the pre-anaesthesia visit like ASA, preoperative comorbidities measured by the POSPOM, CCI, intraoperative parameters like vitals, medication, estimated blood loss and postoperative data obtained from PACU records and discharge letter. Primary Endpoint are postoperative complications assessed with the Cavien-Dindo classification > 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •written informed consense
- •Age > 18 years
- •ASA Score 3 or 4
- •elective non-cardiac high risk surgery
排除标准
- •emergency surgery
- •need for dialysis
- •liver cirrhosis child C
- •intolerance of albumin
- •participation in other AMG (medicines law) study
- •pregnancy or breastfeeding
- •patients with attendants concerning medical matters
- •ASA V patients
- •patients with BMI > 35 kg/m2
结局指标
主要结局
postoperative complications determined with the calvien-dindo classification
时间窗: date of surgery until hospital discharge (approx. 30 days)
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
次要结局
- hospital mortality(date of surgery until hospital discharge (approx. 30 days))
- Acute Kidney Injury(postoperative day 2)
- Myocardial Injury(postoperative day 2)
- 6 months mortalitiy(date of surgery until 6 months after)