NCT03765372

Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients

Evaluation of hsTnT for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,598 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Perioperative/Postoperative Complications
• Outcome

Timeline

• Start date: 2017-06-19
• Primary completion: 2019-11-01
• Completion: 2021-12-18
• First posted: 2018-12-05
• Last updated: 2024-03-06

Locations

1 site across 1 country: Germany