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

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

Study Overview

• Status: Unknown
• Conditions: Perioperative Myocardial Injury

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Eckhard Mauermann, MD; Phone Number: +41(0)61 328 7387; Email: Eckhard.Mauermann@usb.ch
• Study Contact Backup: Name: Giovanna Lurati Buse, MD, MSc; Email: Giovanna.LuratiBuse@med.uni-duesseldorf.de

Study Locations

• Germany
  • Dusseldorf, Germany
    • Recruiting
    • Heinrich Heine University
    • Contact: Giovanna Lurati Buse, MD, MSc; Email: Giovanna.LuratiBuse@med.uni-duesseldorf.de
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department of Anesthesia, University of Basel Hospital
    • Contact: Eckhard Mauermann, MD; Email: Eckhard.Mauermann@usb.ch
    • Sub-Investigator: Eckhard Mauermann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
myocardial injury in non-cardiac surgery (MINS)		3 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality		12 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Giovanna Lurati Buse, MD, MSc, Heinrich Heine University Düsseldorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Copeptin, human
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Pituitary Diseases; Diabetes Insipidus
• Other Study ID Numbers: EKNZ 2015-275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO