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Trial record 4 of 24 for:    Recruiting, Not yet recruiting, Available Studies | Diabetes insipidus

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

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ClinicalTrials.gov Identifier: NCT02687776
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease
Perioperative Myocardial Injury

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
Study Start Date : February 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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

  3. myocardial injury in non-cardiac surgery (MINS) [ Time Frame: 3 postoperative days ]

Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: 12 months ]
  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687776


Contacts
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Contact: Eckhard Mauermann, MD +41(0)61 5565224 Eckhard.Mauermann@usb.ch
Contact: Giovanna Lurati Buse, MD, MSc Giovanna.LuratiBuse@med.uni-duesseldorf.de

Locations
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Germany
Heinrich Heine University Recruiting
Dusseldorf, Germany
Contact: Giovanna Lurati Buse, MD, MSc       Giovanna.LuratiBuse@med.uni-duesseldorf.de   
Switzerland
Department of Anesthesia, University of Basel Hospital Recruiting
Basel, Switzerland, 4031
Contact: Eckhard Mauermann, MD       Eckhard.Mauermann@usb.ch   
Sub-Investigator: Eckhard Mauermann, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Giovanna Lurati Buse, MD, MSc Heinrich Heine University Dusseldorf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02687776     History of Changes
Other Study ID Numbers: EKNZ 2015-275
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin, human

Additional relevant MeSH terms:
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Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs