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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,598
Klinikum Rechts der Isar, Technische Universität München
München, Bavaria, Germany
postoperative complications determined with the calvien-dindo classification
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
Time frame: date of surgery until hospital discharge (approx. 30 days)
hospital mortality
Rate of Mortality among study patients
Time frame: date of surgery until hospital discharge (approx. 30 days)
Acute Kidney Injury
Acute Kidney Injury according to KDIGO
Time frame: postoperative day 2
Myocardial Injury
perioperative hsTnT course, including preoperative hsTnT measurements
Time frame: postoperative day 2
6 months mortalitiy
Rate of Mortality among study patients
Time frame: date of surgery until 6 months after
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