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

Sponsor
Nordsjaellands Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05992961
Collaborator
(none)
558
1
36.9
15.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Troponin I

Study Design

Study Type:
Observational
Actual Enrollment :
558 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Feb 28, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. compare the mortality rate before and after implementing troponin I surveillance [30-, 90-, and 365-day]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copenhagen University Hospital - North Zealand Hillerød Denmark 3400

Sponsors and Collaborators

  • Nordsjaellands Hospital

Investigators

  • Principal Investigator: Claus Anders TB Bertelsen, PhD, MD, Copenhagen University Hospital - North Zealand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nordsjaellands Hospital
ClinicalTrials.gov Identifier:
NCT05992961
Other Study ID Numbers:
  • P-2020-507-2
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023