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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02687776
Other study ID # EKNZ 2015-275
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date December 10, 2021

Study information

Verified date April 2024
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 517
Est. completion date December 10, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Heinrich Heine University Dusseldorf
Switzerland Department of Anesthesia, University of Basel Hospital Basel

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Heinrich-Heine University, Duesseldorf

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary perioperative copeptin concentrations copeptin concentrations for the perioperative time course as measured by the ThermoFisher assay at induction, at 0h, 2h, 4h, 6h, 8h, as well as on the postoperative day 1 and 3. perioperative from induction of anesthesia to the third postoperative day
Primary composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) MACCE defined as:non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke 12 months
Primary myocardial injury in non-cardiac surgery (MINS) 3 postoperative days
Secondary all-cause mortality 12 months
Secondary composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) MACCE: non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke 30 days
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