An observational study in Abdomen, Acute, Myocardial Injury After Non-cardiac Surgery and Troponin I, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Nordsjaellands Hospital · Observational
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.
65 studies on the registry are indexed under Abdomen, Acute; 14 are open to participants now.
This study's enrollment of 558 is above the median of 233 across 36 observational studies indexed under Abdomen, Acute.
Browse Abdomen, Acute studies →Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.
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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.
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Exclusion Criteria:
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 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.
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.
Time frame: 30-, 90-, and 365-day
Plan to share: No — IPD can be shared at request.
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Feb 2021, 36 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Nordsjaellands Hospital