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

NCT02687776 | Completed

• 1 other identifier: EKNZ 2015-275
• Study Type: observational
• Target: 517
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Perioperative Myocardial Injury

Keywords

Copeptin, human

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• all-cause mortality

  12 months

• composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 \[Kristensen\])

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (2)

Heinrich Heine University

Düsseldorf, Germany

Location

Department of Anesthesia, University of Basel Hospital

Basel, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 38243094 RESULT

• 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.

  PMID: 29750698 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Giovanna Lurati Buse, MD, MSc

  Heinrich Heine University Dusseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)