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

Completed

• Conditions: Perioperative Myocardial Injury

• Registration Number: NCT02687776
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)	12 months	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
perioperative copeptin concentrations	perioperative from induction of anesthesia to the third postoperative day	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.
myocardial injury in non-cardiac surgery (MINS)	3 postoperative days

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	12 months
composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)	30 days	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

Trial Locations

Locations (2)

Heinrich Heine University; 🇩🇪 Dusseldorf, Germany

Department of Anesthesia, University of Basel Hospital; 🇨🇭 Basel, Switzerland