Abdomen, AcuteNCT05992961
The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery
An observational study of Abdomen, Acute and Myocardial Injury After Non-cardiac Surgery, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomen, Acute, Myocardial Injury After Non-cardiac Surgery, Troponin I
- What is being tested?
- Troponin I
- How many people
- 558 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Eligible patients were 18 years or older
- Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage.
Who cannot join
- Not undergoing surgery for one of the conditions above
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Troponin I
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin IDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Diagnostic Test: Troponin I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-, 90-, and 365-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Feb 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Anders TB Bertelsen, PhD, MD, Principal investigator, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992961
- Sponsor's protocol ID
- P-2020-507-2
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared at request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05992961
- Acronym / sponsor ID
- P-2020-507-2
- Conditions
- Abdomen, Acute, Myocardial Injury After Non-cardiac Surgery, Troponin I, Myocardial Injury, Emergency Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Troponin IPatients undergoing acute high-risk abdominal surgery during the period March 1, 2019, to February 28, 2021 as well as postoperative troponin I surveillance . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Eligible patients were 18 years or older
- Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage.
Key exclusion criteria (1 listed)
- Not undergoing surgery for one of the conditions above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Troponin ITroponin 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. | Diagnostic test | Patients undergoing troponin I surveillance |
Primary outcome
compare the mortality rate before and after implementing troponin I surveillance
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No. IPD can be shared at request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Anders TB Bertelsen, PhD, MD principal investigator
Copenhagen University Hospital - North Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdomen, Acute and Myocardial Injury After Non-cardiac Surgery, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the mortality rate before and after implementing troponin I surveillance (time frame: 30-, 90-, and 365-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.