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

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765372
• Other study ID #: BiPoC
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: December 18, 2021

Study information

• Verified date: December 2021
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1598
• Est. completion date: December 18, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Outcome
• Perioperative/Postoperative Complications
• Postoperative Complications

Locations

Country	Name	City	State
Germany	Klinikum Rechts der Isar, Technische Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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 Ha — View 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. — View 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. 20 — View 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, Ackla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications determined with the calvien-dindo classification	Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).	date of surgery until hospital discharge (approx. 30 days)
Secondary	hospital mortality	Rate of Mortality among study patients	date of surgery until hospital discharge (approx. 30 days)
Secondary	Acute Kidney Injury	Acute Kidney Injury according to KDIGO	postoperative day 2
Secondary	Myocardial Injury	perioperative hsTnT course, including preoperative hsTnT measurements	postoperative day 2
Secondary	6 months mortalitiy	Rate of Mortality among study patients	date of surgery until 6 months after