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

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

Study Overview

• Status: Completed
• Conditions: Abdomen, Acute; Myocardial Injury After Non-cardiac Surgery
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 341

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Copenhagen University Hospital - North Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing surgery for gastrointestinal perforation, obstruction due to volvulus, tumour, strangulated hernia or adhesions, mesenterial ischemia or necrosis, or anastomotic leakage after gastrointestinal surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of MINS within the first four postoperative days	Postoperative troponin I level equal to or above 59 ng/L	The first four postoperative days

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Chair: Claus A Bertelsen, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Troponin I; Myocardial Injury; Emergency surgery; Myocardial injury after non-cardiac surgery; Abdomen, Acute
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Abdomen, Acute
• Other Study ID Numbers: P-2020-507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No