Troponin I Level and Mortality in Acute Abdominal Surgery

Sponsor

Nordsjaellands Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05933837

Collaborator

(none)

341

Enrollment

Location

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury After Non-cardiac Surgery Abdomen, Acute	Diagnostic Test: Troponin I

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

341 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with MINS Troponin I level equal to or above 59 ng/L	Diagnostic Test: Troponin I Measurements of plasma Troponin I 6-12 hours and on the first four postoperative days after surgery.
Patients without MINS Troponin I level under 59 ng/L	Diagnostic Test: Troponin I Measurements of plasma Troponin I 6-12 hours and on the first four postoperative days after surgery.

Arm

Intervention/Treatment

Patients with MINS

Troponin I level equal to or above 59 ng/L

Diagnostic Test: Troponin I

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

Patients without MINS

Troponin I level under 59 ng/L

Diagnostic Test: Troponin I

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

Outcome Measures

Primary Outcome Measures

The incidence of MINS within the first four postoperative days [The first four postoperative days]
Postoperative troponin I level equal to or above 59 ng/L

Secondary Outcome Measures

The incidence of dynamic plasma Troponin I changes [The first four postoperative days]
Patients with postoperative troponin I level equal to or above 59 ng/L and a change of +20%

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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