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

T

Technical University of Munich

Status

Completed

Conditions

Outcome
Perioperative/Postoperative Complications

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,598 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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