Clinical Trials in Sweden / NCT03436238
Active, not recruiting
Observational
Myocardial Injury in Noncardiac Surgery in Sweden
NCT03436238 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Perioperative/Postoperative ComplicationsRisk Factor, Cardiovascular
Study 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 abdominal surgery.
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
- 30-day mortality — 30 days post surgery
All-cause mortality at 30 days post-surgery. - 30-day MACCE — 30 days post surgery
Major adverse cardio- cerebrovascular events (MACCE) at 30 days post-surgery.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Kristianstad KRYH Hospital | Kristianstad | Skåne County | |
| Eskilstuna Hospital | Eskilstuna | Sweden | |
| Ryhov County Hospital | Jönköping | Sweden | |
| Skane University Hospital Lund | Lund | Sweden | |
| Skane University Hospital Malmö | Malmö | Sweden | |
| Vrinnevi Hospital | Norrköping | Sweden | |
| Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland | Linköping | Östergötland County |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03436238 on ClinicalTrials.gov ↗ ← All trials in Sweden