MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Acute Kidney Injury Clinical Trial

Official title:

Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04681508
• Other study ID #: AHA
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Kidney Injury
• Myocardial Injury
• Pulmonary Disease
• Wounds and Injuries

Intervention

Diagnostic Test:
• Chest CT without contrast enhancement and chest X-ray
Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT

Locations

Country	Name	City	State
Denmark	Nordsjaellands Hospital	Hillerød

Sponsors (3)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Bispebjerg Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with myocardial injury af non-cardiac surgery	Troponin-I above specified level and dynamic changes	30 days
Primary	Mortality rate	Postoperative mortality	30 days
Primary	Mortality rate	Postoperative mortality	90 days
Primary	Mortality rate	Postoperative mortality	1 year
Primary	Acute kidney Injury	According to KIDGO criteria	30 days
Primary	Proportion of patients with pulmonary pathology	Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement	1 day
Primary	Proportion of patients with pulmonary complications	Postoperative complications	30 days