Clinical trial NCT03765372: Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients
Official title: Evaluation of hsTnT for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative/Postoperative Complications
Outcome
Keywords: perioperative outcome
clavien-dindo classification
hsTnT
MINS
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 1598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High risk patients (ASA Status 3 or 4) and / or patients undergoing elective non-cardiac high risk surgery at the Klinikum rechts der Isar, 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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative complications determined with the calvien-dindo classification
timeFrame: date of surgery until hospital discharge (approx. 30 days)
Secondary outcomes:
measure: hospital mortality
timeFrame: date of surgery until hospital discharge (approx. 30 days)
measure: Acute Kidney Injury
timeFrame: postoperative day 2
measure: Myocardial Injury
timeFrame: postoperative day 2
measure: 6 months mortalitiy
timeFrame: date of surgery until 6 months after
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum Rechts der Isar, Technische Universität München
state: Bavaria
Study officials:
affiliation: Department of Anesthesia, Klinikum rechts der Isar, TU Munich
name: Bettina Jungwirth, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.