Status:
ACTIVE_NOT_RECRUITING
Myocardial Injury in Noncardiac Surgery in Sweden
Lead Sponsor:
Linkoeping University
Collaborating Sponsors:
Region Östergötland
Medical Research Council of Southeast Sweden
Conditions:
Perioperative/Postoperative Complications
Risk Factor, Cardiovascular
Eligibility:
All Genders
50+ years
Brief Summary
The purpose of this multicentre, prospective, observational study is to identify robust biochemical markers that predict adverse cardiovascular outcomes and mortality in patients undergoing major abdo...
Detailed Description
Inclusion Adults at least 50 years old undergoing elective, major or major/complex abdominal surgery defined according to the Surgical Outcome Risk Tool (www.sortsurgery.com), requiring general anaest...
Eligibility Criteria
Inclusion
- Adult patients undergoing elective, major abdominal surgery\*.
- (\*Major abdominal surgery requiring general anaesthesia, and requiring at least one overnight stay. Major abdominal surgery is defined as those classified as major OR major/complex by the Surgical Outcome Risk Tool (SORT) (www.sortsurgery.com).
- In essence major surgery is one that penetrates and exposes a body cavity or produces a substantial impairment of physical or physiologic function or involves extensive dissection or transection. Examples of a major abdominal surgery include, but are not limited to, any procedure involving a laparotomy or laparoscopic procedures of the stomach, duodenum, small and large intestine and rectum. It also includes but is not limited to procedures on the reproductive system (total abdominal hysterectomy, salpingo-oophorectomy) and genitourinary system (nephrectomy, cystectomy).)
Exclusion
- Patient not fulfilling inclusion study criteria above and/or clinician refusal and/or non-eligible as defined below.
- Patients undergoing the following surgical procedures will NOT be eligible:
- transplantation
- trauma
- endocrine
- vascular
- endovascular
- The presence of any one of the following will also lead to exclusion of the patient:
- ACS at presentation (clinical assessment or documentation)
- New or decompensated congestive heart failure at presentation (clinical assessment or documentation)
- Documented severe aortic stenosis (valve area \< 1cm2)
- Reduced LVEF (\<40%); if no LVEF is available, it will be assumed to be \>40%
- Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant
Key Trial Info
Start Date :
May 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1269 Patients enrolled
Trial Details
Trial ID
NCT03436238
Start Date
May 15 2017
End Date
December 31 2025
Last Update
November 18 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Kristianstad KRYH Hospital
Kristianstad, Skåne County, Sweden
2
Eskilstuna Hospital
Eskilstuna, Sweden
3
Ryhov County Hospital
Jönköping, Sweden
4
Skane University Hospital Lund
Lund, Sweden