Abdomen, AcuteNCT04681508
MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
A study testing Chest CT without contrast enhancement and chest X-ray in people with Abdomen, Acute and Myocardial Injury, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomen, Acute, Myocardial Injury, Acute Kidney Injury
- What is being tested?
- Chest CT without contrast enhancement and chest X-ray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults (≥18 years).
- Patients included in the AHA regimen undergoing CT on suspicion acute high-risk abdominal disorder e.g.g bowel obstruction GI perforation or ischemia, and need of emergency abdominal surgery, either laparoscopic surgery or laparotomy.
- Able to speak Danish. In case Danish was not spoken an interpreter was used to obtain the informed consent.
- Able to give informed consent.
Who cannot join
- Patients who cannot give informed consent to participate in the study 15 minutes after receiving verbal information regarding the study.
- Known chronic kidney disease requiring dialysis at the time of admission (only exclusion criteria for the part of the study relating to AKI).
- Patients included in the AHA regimen, but conservative treatment is chosen (only exclusion criteria for the part of the study relating to MINS and AKI).
- Patients not resident in Denmark.
- Patients not able to give informed consent.
- Patient not able to speak Danish and not enough time to obtain an interpreter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.
Read the detailed description
The main issues are:
- To investigate if coronary calcification predisposes the development of myocardial injury and causes an increased mortality rate.
- To evaluate the predictive value of NT-pro-BNP in relation to the development of MINS and the mortality rate.
- To evaluate the predictive value of different biomarkers of AKI in relation to which patients develop AKI.
- To examine the proteins, exosomes and single cell RNA during acute kidney injury in order to describe the molecular processes in the kidney during AKI.
- To examine whether a chest CT scan without contrast enhancement will change treatment decisions in the acute gastrointestinal patient compared with a chest x-ray.
- Being tested
- Chest CT without contrast enhancement and chest X-ray
- Medical subject headings
- Abdomen, Acute, Acute Kidney Injury, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT without contrast enhancement and chest X-rayDiagnostic test
Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients undergo chest CT without contrast enhancement and chest X-ray. Blood and urine sampling from patients subsequently undergoing emergency laparoscopy or laparotomy. Otherwise standard care Receives: Diagnostic Test: Chest CT without contrast enhancement and chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with myocardial injury af non-cardiac surgery
Troponin-I above specified level and dynamic changes
Measured: 30 days
Mortality rate
Postoperative mortality
Measured: 30 days
Mortality rate
Postoperative mortality
Measured: 90 days
Mortality rate
Postoperative mortality
Measured: 1 year
Acute kidney Injury
According to KIDGO criteria
Measured: 30 days
Proportion of patients with pulmonary pathology
Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement
Measured: 1 day
Proportion of patients with pulmonary complications
Postoperative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Mar 2021
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Claus A Bertelsen, PhD, Study chair, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681508
- Sponsor's protocol ID
- AHA
- Status last verified
- Aug 2023
- First submitted
- 18 Dec 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04681508
- Acronym / sponsor ID
- AHA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Southern Denmark
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2020 (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.
Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.
Detailed description
The main issues are:
- To investigate if coronary calcification predisposes the development of myocardial injury and causes an increased mortality rate.
- To evaluate the predictive value of NT-pro-BNP in relation to the development of MINS and the mortality rate.
- To evaluate the predictive value of different biomarkers of AKI in relation to which patients develop AKI.
- To examine the proteins, exosomes and single cell RNA during acute kidney injury in order to describe the molecular processes in the kidney during AKI.
- To examine whether a chest CT scan without contrast enhancement will change treatment decisions in the acute gastrointestinal patient compared with a chest x-ray.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Diagnostic Test: Chest CT without contrast enhancement and chest X-rayAll patients undergo chest CT without contrast enhancement and chest X-ray. Blood and urine sampling from patients subsequently undergoing emergency laparoscopy or laparotomy. Otherwise standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years).
- Patients included in the AHA regimen undergoing CT on suspicion acute high-risk abdominal disorder e.g.g bowel obstruction GI perforation or ischemia, and need of emergency abdominal surgery, either laparoscopic surgery or laparotomy.
- Able to speak Danish. In case Danish was not spoken an interpreter was used to obtain the informed consent.
- Able to give informed consent.
Key exclusion criteria (6 listed)
- Patients who cannot give informed consent to participate in the study 15 minutes after receiving verbal information regarding the study.
- Known chronic kidney disease requiring dialysis at the time of admission (only exclusion criteria for the part of the study relating to AKI).
- Patients included in the AHA regimen, but conservative treatment is chosen (only exclusion criteria for the part of the study relating to MINS and AKI).
- Patients not resident in Denmark.
- Patients not able to give informed consent.
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 |
|---|---|---|
| Chest CT without contrast enhancement and chest X-rayChest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT | Diagnostic test | All patients |
Primary outcome
Proportion of patients with myocardial injury af non-cardiac surgery
Time frame: 30 days
Troponin-I above specified level and dynamic changes
Mortality rate
Time frame: 30 days
Postoperative mortality
Mortality rate
Time frame: 90 days
Postoperative mortality
Mortality rate
Time frame: 1 year
Postoperative mortality
Acute kidney Injury
Time frame: 30 days
According to KIDGO criteria
Proportion of patients with pulmonary pathology
Time frame: 1 day
Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement
Proportion of patients with pulmonary complications
Time frame: 30 days
Postoperative complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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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 A Bertelsen, PhD study chair
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest CT without contrast enhancement and chest X-ray in people with Abdomen, Acute and Myocardial Injury, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients with myocardial injury af non-cardiac surgery (time frame: 30 days). The study lists 7 primary outcomes in all. 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 21 Aug 2023.