Clinical trial NCT02687776: Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
Official title: Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Myocardial Injury
Keywords: Copeptin, human
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2016-02-22
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients \>18 years undergoing major vascular surgery will be invited to participate. Specifically, patients undergoing abdominal aortic aneurysm repair, suprainguinal and infrainguinal vascular surgery, as well as carotid surgery will be included. After the first 30 patients, the population is to be expanded to elevated-risk surgeries in general.

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


Eligibility criteria: 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

Primary outcomes:
measure: perioperative copeptin concentrations
timeFrame: perioperative from induction of anesthesia to the third postoperative day
measure: composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 12 months
measure: myocardial injury in non-cardiac surgery (MINS)
timeFrame: 3 postoperative days
Secondary outcomes:
measure: all-cause mortality
timeFrame: 12 months
measure: composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 30 days
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Heinrich Heine University
city: Basel
country: Switzerland
facility: Department of Anesthesia, University of Basel Hospital
Study officials:
affiliation: Heinrich Heine University Dusseldorf
name: Giovanna Lurati Buse, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.