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Troponin I Level and Mortality in Acute Abdominal Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05933837
Enrollment
341
Registered
2023-07-06
Start date
2019-03-01
Completion date
2022-02-28
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomen, Acute, Myocardial Injury After Non-cardiac Surgery

Keywords

Myocardial injury after non-cardiac surgery, Abdomen, Acute, Troponin I, Myocardial Injury, Emergency surgery

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.

Interventions

DIAGNOSTIC_TESTTroponin I

Measurements of plasma Troponin I 6-12 hours and on the first four postoperative days after surgery.

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of MINS within the first four postoperative daysThe first four postoperative daysPostoperative troponin I level equal to or above 59 ng/L

Secondary

MeasureTime frameDescription
The incidence of dynamic plasma Troponin I changesThe first four postoperative daysPatients with postoperative troponin I level equal to or above 59 ng/L and a change of +20%

Other

MeasureTime frameDescription
The association between MINS and all-course mortality within 30 days, 90 days, and 1 year30-day, 90-day and 1-yearMINS defined as troponin I equal to or above 59 ng/L and mortality as yes/no

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026