Troponin I Level and Mortality in Acute Abdominal Surgery

NCT05933837 | Completed DMC

• 1 other identifier: P-2020-507
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Myocardial Injury After Non-cardiac Surgery; Abdomen, Acute

Keywords

Myocardial injury after non-cardiac surgery; Abdomen, Acute; Troponin I; Myocardial Injury; Emergency surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of dynamic plasma Troponin I changes

  The first four postoperative days

Other Outcomes (1)

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

  30-day, 90-day and 1-year

Study Arms (2)

Patients with MINS

Troponin I level equal to or above 59 ng/L

Diagnostic Test: Troponin I

Patients without MINS

Troponin I level under 59 ng/L

Diagnostic Test: Troponin I

Interventions

Troponin I DIAGNOSTIC_TEST

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

Patients with MINS; Patients without MINS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing surgery for gastrointestinal perforation, obstruction due to volvulus, tumour, strangulated hernia or adhesions, mesenterial ischemia or necrosis, or anastomotic leakage after gastrointestinal surgery.

You may qualify if:

• years or older
• Patients undergoing acute high-risk abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Kanstrup CTB, Serup CM, Svarre KJ, Rasmussen MC, Lundstrom LH, Kleif J, Bertelsen CA. Association between troponin I levels and mortality among patients undergoing acute high-risk abdominal surgery-A cohort study. World J Surg. 2024 Feb;48(2):361-370. doi: 10.1002/wjs.12035. Epub 2024 Jan 12.

  PMID: 38284768 DERIVED

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Claus A Bertelsen

  Nordsjaellands Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 6, 2023
• Study Start: March 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)