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.

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Key information

Conditions

Perioperative Myocardial Injury Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heinrich Heine University, Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

perioperative copeptin concentrations

Time frame: perioperative from induction of anesthesia to the third postoperative day

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

Time frame: 12 months

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
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)

Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

Heinrich-Heine University, Duesseldorf

Registry information

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Feb 22, 2016
Registry last updated: Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed