Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients
NCT ID: NCT03765372
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1598 participants
OBSERVATIONAL
2017-06-19
2021-12-18
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* ASA Score 3 or 4
* elective non-cardiac high risk surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Bettina Jungwirth, Prof.
Role: STUDY_DIRECTOR
Department of Anesthesia, Klinikum rechts der Isar, TU Munich
Locations
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Klinikum Rechts der Isar, Technische Universität München
München, Bavaria, Germany
Countries
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References
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Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.
Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
Ma J, Xin Q, Wang X, Gao M, Wang Y, Liu J. Prediction of perioperative cardiac events through preoperative NT-pro-BNP and cTnI after emergent non-cardiac surgery in elderly patients. PLoS One. 2015 Mar 23;10(3):e0121306. doi: 10.1371/journal.pone.0121306. eCollection 2015.
Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.
Other Identifiers
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BiPoC
Identifier Type: -
Identifier Source: org_study_id
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