Perioperative Myocardial InjuryNCT02687776
Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
An observational study of Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Myocardial Injury
- How many people
- 517 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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])
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Department of Anesthesia, University of Basel Hospital
Basel, 4031
About this study
Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.
- Conditions
- Perioperative Myocardial Injury
- Keywords
- Copeptin, human
- Medical subject headings
- Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
myocardial injury in non-cardiac surgery (MINS)
Measured: 3 postoperative days
Secondary outcomes (2)
all-cause mortality
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor
- Investigators
- Giovanna Lurati Buse, MD, MSc, Principal investigator, Heinrich Heine University Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687776
- Sponsor's protocol ID
- EKNZ 2015-275
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2016
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38243094Kamber 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.
PubMed 29750698
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT02687776
- Acronym / sponsor ID
- EKNZ 2015-275
- Conditions
- Perioperative Myocardial Injury
- Keywords
- Copeptin, human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- Feb 2016
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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])
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Results publication: PubMed 38243094Kamber 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.
- Derived from this study: PubMed 29750698Kamber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Lurati Buse, MD, MSc principal investigator
Heinrich Heine University Dusseldorf
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative copeptin concentrations (time frame: perioperative from induction of anesthesia to the third postoperative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.