Clinical trial NCT04681508: MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Official title: Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdomen, Acute
Myocardial Injury
Acute Kidney Injury
Pulmonary Disease
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University of Southern Denmark
First posted: 2020-12-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of patients with myocardial injury af non-cardiac surgery
timeFrame: 30 days
measure: Mortality rate
timeFrame: 30 days
measure: Mortality rate
timeFrame: 90 days
measure: Mortality rate
timeFrame: 1 year
measure: Acute kidney Injury
timeFrame: 30 days
measure: Proportion of patients with pulmonary pathology
timeFrame: 1 day
measure: Proportion of patients with pulmonary complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Claus A Bertelsen, PhD
role: STUDY_CHAIR
References: