The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery

Treatment of disorders such as gastrointestinal tract (GI) perforation, ischemia and obstruction often require acute high-risk abdominal surgery, which is associated with a high risk of complications such as myocardial injury after non-cardiac surgery (MINS) and mortality. The majority of patients with MINS will not experience any symptoms, and thus MINS remains undetected without routine troponin measurements.

The investigators hypothesized that implementing surveillance with troponin I as a standard care might be useful as risk stratification, and that increased surveillance, examinations, and subsequent individually based medical interventions, might improve the outcomes for patients with MINS.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Eligible patients were 18 years or older
Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage.

Exclusion criteria

Not undergoing surgery for one of the conditions above

Treatment and study plan

Troponin I

Diagnostic Test

Troponin I were measured 6-12 hours postoperatively and on each of the succeeding four postoperative days for patients operated March 1, 2019, to February 28, 2021.

Patients with increased troponin I levels were assessed regarding symptoms of myocardial ischaemia including electrocardiography. Each patient was individually assessed, and relevant treatment and follow-up were planned in collaboration between surgeons, cardiologists, and anaesthesiologists.

Primary outcomes

compare the mortality rate before and after implementing troponin I surveillance

Time frame: 30-, 90-, and 365-day

compare the 30-, 90-, and 365-day mortality rate after acute hugh-risk abdominal surgery in patients undergoing postoperative troponin I surveillance and subsequent intervention with a historical group of patients not undergoing troponin I surveillance.

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Aug 15, 2023
Registry last updated: Aug 18, 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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