Troponin I Level and Mortality in Acute Abdominal Surgery

Abdomen, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933837
• Other study ID #: P-2020-507
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2023
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute

Intervention

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

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
Other	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
Primary	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	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