Troponin I Level and Mortality in Acute Abdominal Surgery

NCT ID: NCT05933837

Last Updated: 2023-07-06

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

341 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Myocardial Injury After Non-cardiac Surgery Abdomen, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MINS

Troponin I level equal to or above 59 ng/L

Troponin I

Intervention Type DIAGNOSTIC_TEST

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

Patients without MINS

Troponin I level under 59 ng/L

Troponin I

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Troponin I

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
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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Charlotte Tiffanie Bendtz Kanstrup

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claus A Bertelsen

Role: STUDY_CHAIR

Nordsjaellands Hospital

Locations

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Copenhagen University Hospital - North Zealand

Hillerød, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38284768 (View on PubMed)

Other Identifiers

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P-2020-507

Identifier Type: -

Identifier Source: org_study_id

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