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Clinical Trials/NCT05933837
NCT05933837
Completed
Not Applicable

Association Between Troponin I Levels and Mortality Among Patients Undergoing Acute High-risk Abdominal Surgery - a Cohort Study

Nordsjaellands Hospital1 site in 1 country341 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Injury After Non-cardiac Surgery
Sponsor
Nordsjaellands Hospital
Enrollment
341
Locations
1
Primary Endpoint
The incidence of MINS within the first four postoperative days
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery.

MINS is defined as at least one increased single measurement of plasma troponin I (TnI). TnI-dynamic is defined as either two succeeding measurements of TnI > 59 ng/l with an increase/fall of more than 20%, or by one measurements of TnI > 59 ng/l with a succeeding measurement of TnI < 59 ng/l and a decrease of more than 50%.

Participants will have plasma TnI measured 6-12 hours postoperatively and on each of the following four postoperative days. Follow-up will be minimum one year after surgery.

The aim of the study is to determine:

  • The incidence of MINS within the first four postoperative days
  • The incidence of dynamic TnI changes
  • The association between MINS and dynamic TnI changes respectively and all-course short-term mortality

Detailed Description

Gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. Myocardial injury after non-cardiac surgery (MINS) is a frequent but often unrecognized postoperative complication. MINS is associated with an increased risk of other cardiac complications and 30-day mortality. However, the literature on MINS is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic TnI-criteria used for acute myocardial injury has any association with mortality in patients with MINS. This study aims to estimate the incidence of MINS in patients undergoing AHA surgery, and the association between the short-term mortality and MINS defined as a single increased measurement of TnI and as TnI dynamics respectively.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
February 28, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Nordsjaellands Hospital
Responsible Party
Principal Investigator
Principal Investigator

Charlotte Tiffanie Bendtz Kanstrup

PhD, MD

Nordsjaellands Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Patients undergoing acute high-risk abdominal surgery

Exclusion Criteria

  • Patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage
  • If further treatment postoperatively was assessed as futile and terminated immediately after surgery

Outcomes

Primary Outcomes

The incidence of MINS within the first four postoperative days

Time Frame: The first four postoperative days

Postoperative troponin I level equal to or above 59 ng/L

Secondary Outcomes

  • The incidence of dynamic plasma Troponin I changes(The first four postoperative days)

Study Sites (1)

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