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

Myocardial Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992961
• Other study ID #: P-2020-507-2
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2023
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Emergencies
• Emergency Surgery
• Myocardial Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Troponin I
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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - North Zealand	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the mortality rate before and after implementing troponin I surveillance	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.	30-, 90-, and 365-day