NCT03765372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2021

Completed
Last Updated

March 6, 2024

Status Verified

December 1, 2021

Enrollment Period

2.4 years

First QC Date

November 28, 2018

Last Update Submit

March 4, 2024

Conditions

Perioperative/Postoperative ComplicationsOutcome

Keywords

perioperative outcomeclavien-dindo classificationhsTnTMINS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • hospital mortality

    date of surgery until hospital discharge (approx. 30 days)

  • Acute Kidney Injury

    postoperative day 2

  • Myocardial Injury

    postoperative day 2

  • 6 months mortalitiy

    date of surgery until 6 months after

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Rechts der Isar, Technische Universität München

München, Bavaria, 81675, Germany

Location

Related 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 Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.

    PMID: 28796275RESULT

  • 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.

    PMID: 28444280RESULT

  • 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.

    PMID: 25799524RESULT

  • 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.

    PMID: 22387082RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bettina Jungwirth, Prof.

    Department of Anesthesia, Klinikum rechts der Isar, TU Munich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2018

First Posted

December 5, 2018

Study Start

June 19, 2017

Primary Completion

November 1, 2019

Study Completion

December 18, 2021

Last Updated

March 6, 2024

Record last verified: 2021-12

Locations

DE(1)