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NCT Number: NCT05933837

Troponin I Level and Mortality in Acute Abdominal Surgery

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

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Key information

Conditions

Myocardial Injury After Non-Cardiac Surgery Abdomen, Acute Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Troponin I

Diagnostic Test

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

Primary outcomes

  1. 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

  1. The incidence of dynamic plasma Troponin I changes

    Time frame: The first four postoperative days

    Patients with postoperative troponin I level equal to or above 59 ng/L and a change of +20%

Other outcomes

  1. The association between MINS and all-course mortality within 30 days, 90 days, and 1 year

    Time frame: 30-day, 90-day and 1-year

    MINS defined as troponin I equal to or above 59 ng/L and mortality as yes/no

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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