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

Completed

• Conditions: Outcome; Perioperative/Postoperative Complications

• Registration Number: NCT03765372
• Lead Sponsor: Technical University of Munich

Brief 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.

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Primary Completion: 2019-11-01
• Status Verified: 2021-12
• Study Completion: 2021-12-18
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1598

Inclusion Criteria

• written informed consense
• Age > 18 years
• ASA Score 3 or 4
• elective non-cardiac high risk surgery

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative complications determined with the calvien-dindo classification	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).

Secondary Outcome Measures

Name	Time	Method
hospital mortality	date of surgery until hospital discharge (approx. 30 days)	Rate of Mortality among study patients
Acute Kidney Injury	postoperative day 2	Acute Kidney Injury according to KDIGO
Myocardial Injury	postoperative day 2	perioperative hsTnT course, including preoperative hsTnT measurements
6 months mortalitiy	date of surgery until 6 months after	Rate of Mortality among study patients

Trial Locations

Locations (1)

Klinikum Rechts der Isar, Technische Universität München; 🇩🇪 München, Bavaria, Germany