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

Perioperative Myocardial Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687776
• Other study ID #: EKNZ 2015-275
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Perioperative Myocardial Injury

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