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

NCT05992961 | Completed DMC

• 1 other identifier: P-2020-507-2
• Study Type: observational
• Target: 558
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdomen, Acute; Myocardial Injury After Non-cardiac Surgery; Troponin I; Myocardial Injury; Emergency Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients not undergoing troponin I surveillance

Patients undergoing acute high-risk abdominal surgery during the period February 1, 2018, to February 28, 2019. No troponin I measurements were made.

Patients undergoing troponin I surveillance

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

Diagnostic Test: Troponin I

Interventions

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.

Patients undergoing troponin I surveillance

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 acute high-risk abdominal surgery at Copenhagen University Hospital - North Zealand, Denmark during the period February 1, 2018, to February 28, 2021. For patients undergoing acute high-risk abdominal surgery on more than occasion during the period of observation, only the first case of surgery was included.

You may qualify if:

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

You may not qualify if:

• Not undergoing surgery for one of the conditions above

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

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 Anders TB Bertelsen, PhD, MD

  Copenhagen University Hospital - North Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: February 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)