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

Completed

• Conditions: Myocardial Injury After Non-cardiac Surgery; Emergency Surgery; Myocardial Injury; Abdomen, Acute; Troponin I
• Interventions: Diagnostic Test: Troponin I

• Registration Number: NCT05992961
• Lead Sponsor: Nordsjaellands Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2023-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing troponin I surveillance	Troponin I	Patients undergoing acute high-risk abdominal surgery during the period March 1, 2019, to February 28, 2021 as well as postoperative troponin I surveillance .

Primary Outcome Measures

Name	Time	Method
compare the mortality rate before and after implementing troponin I surveillance	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.

Trial Locations

Locations (1)

Copenhagen University Hospital - North Zealand; 🇩🇰 Hillerød, Denmark