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

NCT ID: NCT05992961

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

558 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-02-28

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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 .

Troponin I

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus Anders TB Bertelsen, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital - North Zealand

Locations

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Copenhagen University Hospital - North Zealand

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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P-2020-507-2

Identifier Type: -

Identifier Source: org_study_id

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