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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02687776
Enrollment
517
Registered
2016-02-22
Start date
2016-02-29
Completion date
2021-12-10
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Myocardial Injury

Keywords

Copeptin, human

Brief summary

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

Interventions

None listed

Sponsors

Heinrich-Heine University, Duesseldorf
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
perioperative copeptin concentrationsperioperative from induction of anesthesia to the third postoperative daycopeptin 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.
composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)12 monthsMACCE 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
myocardial injury in non-cardiac surgery (MINS)3 postoperative days

Secondary

MeasureTime frameDescription
all-cause mortality12 months
composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)30 daysMACCE: non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026