Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery

NCT ID: NCT02687776

Last Updated: 2024-04-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2021-12-10

Brief Summary

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Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.

Detailed Description

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Conditions

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Perioperative Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults \>18 years
* Type of surgery for patients 1 to 30: abdominal aortic aneurysm repair, suprainguinal and infrainguinal vascular surgery, carotid surgery
* Type of surgery for patients 31 to 500: surgeries with elevated risks in general (as specified by 2014 ESC/ESA Guidelines on non-cardiac surgery:

cardiovascular assessment and management \[Kristensen\])

Exclusion Criteria

* acute coronary Syndrome (ACS) at presentation (clinical assessment or documentation)
* Congestive heart failure at presentation (clinical assessment or documentation)
* Documented severe aortic stenosis (valve area \<1cm2)
* Kidney dysfunction (clearance \<50ml/min)
* Reduced left ventricular ejection fraction (LVEF) (\<40%); if no LVEF is available, it will be assumed to be \>40%
* Cancelled surgery
* Unwilling or unable to provide consent
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanna Lurati Buse, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Heinrich Heine University Dusseldorf

Locations

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Heinrich Heine University

Düsseldorf, , Germany

Site Status

Department of Anesthesia, University of Basel Hospital

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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Kamber F, Roth S, Bolliger D, Seeberger E, Nienhaus J, Mueller C, Lurati Buse G, Mauermann E. Perioperative copeptin: predictive value and risk stratification in patients undergoing major noncardiac surgery-a prospective observational cohort study. Can J Anaesth. 2024 Mar;71(3):330-342. doi: 10.1007/s12630-023-02677-y. Epub 2024 Jan 19.

Reference Type RESULT
PMID: 38243094 (View on PubMed)

Kamber F, Mauermann E, Seeberger E, Guerke L, Mueller C, Bolliger D, Lurati Buse GAL. Peri-operative copeptin concentrations and their association with myocardial injury after vascular surgery: A prospective observational cohort study. Eur J Anaesthesiol. 2018 Sep;35(9):682-690. doi: 10.1097/EJA.0000000000000815.

Reference Type DERIVED
PMID: 29750698 (View on PubMed)

Other Identifiers

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EKNZ 2015-275

Identifier Type: -

Identifier Source: org_study_id

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