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

N/ACompletedNCT02687776

University Hospital, Basel, Switzerland517 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

517

Conditions

Perioperative Myocardial Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Heinrich Heine University

Düsseldorf, Germany

Department of Anesthesia, University of Basel Hospital

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 12 months

myocardial injury in non-cardiac surgery (MINS)

Time frame: 3 postoperative days

Secondary Outcomes

all-cause mortality

Time frame: 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

Time frame: 30 days

Data from ClinicalTrials.gov

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